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Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer (POSITIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02308085
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Alliance for Clinical Trials in Oncology
Canadian Cancer Trials Group
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group

Brief Summary:
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

Condition or disease Intervention/treatment Phase
Early Breast Cancer Other: Endocrine therapy interruption Not Applicable

Detailed Description:

Recent decades have witnessed a delay in childbearing for a variety of reasons including cultural, educational, and professional. As a consequence, breast cancer in young women often occurs before the completion of reproductive plans. Infertility has a significant impact on quality of life, resulting in substantial distress in younger women with breast cancer and influencing treatment decisions in a consistent proportion of patients.The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence.For women desiring pregnancy after a breast cancer, 5-10 years of endocrine therapy may substantially reduce the chance of conception; however, a shorter duration of endocrine therapy in this population has not been studied in a prospective manner.

Birth outcome after breast cancer has not been shown to be different from that of the normal population, but increased risks of delivery complications, cesarean section, preterm birth and low birth weight have been reported.

Endocrine agents are potentially teratogenic: taking into account their median half-life, waiting 3 months after their interruption before attempting conception is considered safe.

The limited evidence available on breastfeeding after breast cancer reports successful lactation from the treated breast in approximately 30% of women without detrimental effect on survival. No prospective definitive data are available.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy
Study Start Date : December 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Endocrine therapy interruption
Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.
Other: Endocrine therapy interruption

3 months wash-out between treatment interruption and pregnancy attempt. Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive.

Endocrine therapy resumption. Completion of full duration of endocrine therapy according to individual risk, institutional policy or patient's preference.





Primary Outcome Measures :
  1. Breast Cancer free interval (BCFI) [ Time Frame: From enrollment until the first invasive BC event, assessed up to 14 years ]
    Kaplan-Meier Analysis


Secondary Outcome Measures :
  1. Information on Menstruation recovery and pattern [ Time Frame: Up to 24 months after enrollment ]
    Menstrual diary

  2. Pregnancy rate (determined by pregnancy test) [ Time Frame: Up to 24 months after enrollment ]
    Pregnancy test

  3. Pregnancy outcome [ Time Frame: Up to 33 months after enrollment ]
    Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.

  4. Offspring outcome [ Time Frame: Up to 33 months after enrollment ]
    Collect information on preterm birth, low birth weight, births defects rates.

  5. Breastfeeding pattern [ Time Frame: Up to 36 months after enrollment ]
    Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity

  6. Use of assisted reproductive Technology (ART) [ Time Frame: Up to 24 months after enrollment ]
    ART use will be tabulated

  7. Distant recurrence-free interval (DRFI) [ Time Frame: Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years ]
    Kaplan-Meier Analysis



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤ 42 years at enrollment.
  • Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer.

Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible.

  • The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
  • Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible.
  • Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent.

Note:

  • Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible.
  • Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible.
  • Patients with BRCA1/2 mutations are eligible.
  • Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and patient's desire.
  • Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record.
  • Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record.
  • Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment.
  • Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial.
  • The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  • Patient must be accessible for follow-up.

Exclusion Criteria:

  • Post-menopausal patients at BC diagnosis, as determined locally.
  • History of hysterectomy, bilateral oophorectomy or ovarian irradiation.
  • Patients with current local, loco-regional relapse and/or distant metastatic breast cancer.
  • Patients with a history of prior (ipsi- and/or contralateral) invasive BC.
  • Patients with previous or concomitant non-breast invasive malignancy.
  • Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix.
  • Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
  • Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable.
  • Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308085


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Locations
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United States, California
Cedars Sinai Medical Centre Recruiting
Los Angeles, California, United States, 90211
Contact: Philomena F McAndrew, MD    310-888-8680    mcandrewp@toweroncology.com   
Principal Investigator: Philomena F McAndrew, MD         
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94305
Contact: Irene Wapnir, MD    650-721-5705    wapnir@stanford.edu   
Principal Investigator: Irene Wapnir, MD         
United States, Colorado
University of Colorado Cancer Centre - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Virginia Borges, MD    720-848-1030    virginia.borges@ucdenver.edu   
Principal Investigator: Virginia Borges, MD         
Rocky Mountain Cancer Center Recruiting
Boulder, Colorado, United States, 80303
Contact: Karen Sturtz, MD    303-777-2663    KSturtz@co-cancerresearch.org   
Principal Investigator: Karen M Sturtz, MD         
SCL Health Saint Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Karen Sturtz, MD    303-777-2663    KSturtz@co-cancerresearch.org   
Principal Investigator: Karen Sturtz, MD         
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Virginia Borges, MD    720-848-1030    virginia.borges@ucdenver.edu   
Principal Investigator: Virginia Borges, MD         
United States, Connecticut
Smilow Cancer Hospital-Derby Care Center Recruiting
Derby, Connecticut, United States, 06418
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital Care Center-Fairfield Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital Care Center at Saint Francis Recruiting
Hartford, Connecticut, United States, 06105
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Yale University - Yale Cancer Centre Recruiting
New Haven, Connecticut, United States, 06520
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Yale-New Haven Hospital North Haven Medical Center Recruiting
North Haven, Connecticut, United States, 06473
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital-Orange Care Center Recruiting
Orange, Connecticut, United States, 06477
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital-Torrington Care Center Recruiting
Torrington, Connecticut, United States, 06790
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Contact: Andrea Silber         
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital Care Center-Trumbull Recruiting
Trumbull, Connecticut, United States, 06611
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
Smilow Cancer Hospital-Waterbury Care Center Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Andrea Silber, MD       andrea.silber@yale.edu   
Principal Investigator: Andrea Silber, MD         
United States, Delaware
Helen F. Graham Cancer Center, 4701 Ogletown-Stanton Road Recruiting
Newark, Delaware, United States, 19713
Contact: Gregory A Masters, MD       gmasters@cbg.org   
Principal Investigator: Gregory A Masters, MD         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Gregory A Masters, MD       gmasters@cbg.org   
Principal Investigator: Gregory A Masters, MD         
Medical Oncology Hematology Consultants PA Recruiting
Newport, Delaware, United States, 19713
Contact: Gregory A Masters, MD       gmasters@cbg.org   
Principal Investigator: Gregory A Masters, MD         
Regional Hematology Oncology Practice Associates Recruiting
Newport, Delaware, United States, 19713
Contact: Gregory A Masters, MD       gmasters@cbg.org   
Principal Investigator: Gregory A Masters, MD         
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Asma A Dilawari, MD    202-444-3677    Asma.A.Dilawari@gunet.georgetown.edu   
Principal Investigator: Asma A Alawari, MD         
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Karen Smith       ksmith60@jhmi.edu   
Principal Investigator: Karen Smith         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Jane L Meisel, MD    404-778-7797    jane.l.meisel@emory.edu   
Principal Investigator: Jane L Meisel, MD         
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jane L Meisel, MD    404-778-7797    jane.l.meisel@emory.edu   
Principal Investigator: Jane L Meisel, MD         
United States, Hawaii
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96701
Contact: Jeffrey L Berenberg, MD    808-586-2979    jeffrey.l.berenberg.civ@mail.mil   
Principal Investigator: Jeffrey L Berenberg, MD         
OnCare Hawaii Inc - POB I Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L Berenberg, MD    808-586-2979    jeffrey.l.berenberg.civ@mail.mil   
Principal Investigator: Jeffrey L Berenberg, MD         
Queen's Medical Centre Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L Berenberg, MD    808-586-2979    jeffrey.l.berenberg.civ@mail.mil   
Principal Investigator: Jeffrey L Berenberg, MD         
OnCare Hawaii-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L Berenberg, MD    808-586-2979    jeffrey.l.berenberg.civ@mail.mil   
Principal Investigator: Jeffrey L Berenberg, MD         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Thomas E Lad, MD    312-864-7260    Tlad@cookcountyhhs.org   
Principal Investigator: Thomas E Lad, MD         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Kendrith L Rowland Jr, MD    217-383-6828    kendrith.rowland@carle.com   
Principal Investigator: Kendrith L Rowland Jr, MD         
Carle Physician Group - Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Kendrith M Rowland Jr, MD    217-383-6828    kendrith.rowland@carle.com   
Principal Investigator: Kendrith M Rowland, MD         
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Poornima E Saha, MD    847-570-2515    psaha@northshore.org   
Principal Investigator: Poornima Saha, MD         
Northwestern University Recruiting
Evanston, Illinois, United States, 60201
Contact: Lisa Flaum, MD    312-695-0990    lflaum@nm.org   
Principal Investigator: Lisa Flaum, MD         
NorthShore University Health System - Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Poornima Saha, MD    847-570-2112    psaha@northshore.org   
Principal Investigator: Poornima Saha, MD         
NorthShore Unversity Health System - Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60035
Contact: Poornima Saha, MD    847-570-2112    psaha@northshore.org   
Principal Investigator: Poornima Saha, MD         
Carle Physician Group - Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Kendrith M Rowland Jr, MD    217-383-6828    kendrith.rowland@carle.com   
Principal Investigator: Kendrith M Rowland Jr, MD         
NorthShore Medical Centre Recruiting
Skokie, Illinois, United States, 60076
Contact: Poornima Saha, MD    847-570-2515    psaha@northshore.org   
Principal Investigator: Poornima Saha, MD         
Carle Cancer Centre Recruiting
Urbana, Illinois, United States, 61801
Contact: Kendrith M Rowland Jr, MD    217-383-6828    Kendrith.rowland@carle.com   
Principal Investigator: Kendrith M Rowland Jr, MD         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Kendrith M Rowland Jr, MD    217-383-6828    kendrith.rowland@carle.com   
Principal Investigator: Kendrith M Rowland Jr, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Tarah Ballinger, MD    317-944-3553    tarahb@iu.edu   
Principal Investigator: Tarah Ballinger, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Karen Smith, MD    202-660-6500    ksmith60@jhmi.edu   
Principal Investigator: Karen Smith, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215-5450
Contact: Ann Partridge, MD    617-632-3800    Ann_Partridge@dfci.harvard.edu   
Principal Investigator: Ann Partridge         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
IHA Hematology Consultants-Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
Saint Joseph Mercy Hospital - Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Tareq A Baghdadi    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
IHA Hematology Consultants-Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
Saint Joseph Mercy Hospital- Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
IHA Hematology Consultants-Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
Saint Joseph Mercy Hospital - Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Tareq A Baghdadi, MD    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
IHA Hematology Oncology Consultants-Ann Arbor Recruiting
Ypsilanti, Michigan, United States, 48198
Contact: Tareq A Baghdadi    734-712-1000    tareq_albaghdadi@ihacares.com   
Principal Investigator: Tareq A Baghdadi, MD         
United States, Minnesota
Sanford Clinic North - Bemidji Recruiting
Bemidji, Minnesota, United States, 56501
Contact: Preston Steen, MD    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel M Anderson, MD    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805-1951
Contact: Bret Friday, MD    218-786-3625    Bret.Friday@essentiahealth.org   
Principal Investigator: Bret Friday, MD         
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel M Anderson, MD    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
St John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M Anderson, MD    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
Abbott-Northwestern Hospital, 800 East 28th Street Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Daniel M Anderson, MD    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
Hennepin County Medical Center - Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Daniel M Anderson    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Kathryn Ruddy, MD       Ruddy.Kathryn@mayo.edu   
Principal Investigator: Kathryn Ruddy, MD         
Park Nicollet Methodist Hospital Recruiting
Saint Louis Park, Minnesota, United States, 55343
Contact: Daniel M Anderson    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Daniel M Anderson, MD    952-993-1517    daniel.m.anderson@healthpartners.com   
Principal Investigator: Daniel M Anderson, MD         
United States, Missouri
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P Lyss, MD    314-996-5569    alyss@bjc.org   
Principal Investigator: Alan P Lyss, MD         
United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin Marchello, MD    406-969-6060    bmarchello@mtcancer.org   
Principal Investigator: Benjamin Marchello, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Gary N Schwarz, MD       Gary.N.Schwartz@hitchcock.org   
Principal Investigator: Gary N Schwarz, MD         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Zoneddy Dayao, MD       ZDayao@salud.unm.edu   
Principal Investigator: Zoneddy Dayao, MD         
United States, New York
Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road Recruiting
Bronx, New York, United States, 10461
Contact: Joseph A Sparano, MD       jsparano@montefiore.org   
Principal Investigator: Joseph A Sparano, MD         
Montefiore Medical Center-Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Joseph A Sparano, MD       jsparano@montefiore.org   
Principal Investigator: Joseph A Sparano, MD         
Montefiore Medical Center - Moses Campus, 111 East 210th Street Recruiting
Bronx, New York, United States, 10467
Contact: Joseph A Sparano, MD       jsparano@montefiore.org   
Principal Investigator: Joseph A Sparano, MD         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Tessa Cigler, MD    212-821-0736    tec9002@med.cornell.edu   
Principal Investigator: Tessa Cigler, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Mijung Lee, MD    315-464-4353    leemij@upstate.edu   
Principal Investigator: Mijung Lee, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carey Anders, MD    919-843-7719    carey_anders@med.unc.edu   
Principal Investigator: Carey Anders         
Southeastern Medical Oncology Centre Recruiting
Clinton, North Carolina, United States, 28328
Contact: Jim Atkins, MD    919-580-0000    dratkins@cancersmoc.com   
Principal Investigator: Jim Atkins, MD         
Southeastern Medical Oncology Centre Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Jim Atkins, MD    919-580-0000    dratkins@cancersmoc.com   
Principal Investigator: Jim Atkind, MD         
Southeastern Medical Oncology Centre Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: Jim Atkins, MD    919-580-0000    dratkins@camcersmoc.com   
Principal Investigator: Jim Atkins, MD         
Southeastern Medical Oncology Centre Recruiting
Wilson, North Carolina, United States, 27534
Contact: Jim Atkins, MD    919-580-0000    dratkins@cancersmoc.com   
Principal Investigator: Jim Atkins, MD         
United States, North Dakota
Sanford Bismark Medical Centre Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston Steen, MD    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
Sanford Roger Maris Cancer Centre Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston Steen, MD    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
Sanford Broadway Medical Centre Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston Steen, MD    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
United States, Pennsylvania
UPMC-Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Gisberta Van Londen, MD    412-692-2382    vanlondenj@upmc.edu   
Principal Investigator: Gisberta Van Londen, MD         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Sonali V Pandya, MD    401-453-7540    svpandya@wihri.org   
Principal Investigator: Sonali V Pandya, MD         
United States, South Carolina
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29611
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Amarinthia Curtis, MD    864-560-6812    acurtis@gibbscc.org   
Principal Investigator: Amarinthia Curtis, MD         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jefferey K Giguere, MD       jgiguere@ghs.org   
Principal Investigator: Jefferey K Giguere, MD         
United States, South Dakota
Sanford Cancer Centre Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Preston Steen    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
Sanford USD Medical Centre - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Preston Steen, MD    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston Steen, MD         
United States, Texas
Doctor's Hospital of Laredo Recruiting
Laredo, Texas, United States, 78045
Contact: Gary W Unzeitig, MD       drgwu@laredobreastcare.com   
Principal Investigator: Gary W Unzeitig, MD         
United States, Utah
Huntsman Cancer Institute / University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Nora L Henry, MD    801-585-0255    lynn.henry@hci.utah.edu   
Principal Investigator: Nora L Henry, MD         
United States, Virginia
Bon Secours Memorial Regional Medical Centre Recruiting
Mechanicsville, Virginia, United States, 23116
Contact: William Irvin Jr, MD    804-893-8717    William_Irvin@bshsi.org   
Principal Investigator: William Irvin Jr, MD         
Bon Secours Saint Francis Medical Centre Recruiting
Midlothian, Virginia, United States, 23114
Contact: William Irvin Jr, MD    804-893-8717    William_Irvin@bshsi.org   
Principal Investigator: William Irvin, MD         
Bon Secours Saint Mary's Hospital Recruiting
Richmond, Virginia, United States, 23223
Contact: William Irvin Jr, MD    804-893-8717    William_Irvin@bshsi.org   
Principal Investigator: William Irvin, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Larissa A Korde, MD       lkorde@u.washington.edu   
Principal Investigator: Larissa A Korde, MD         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Rachel L Yung, MD    206-606-7703    rlyung@seattlecca.org   
Principal Investigator: Rachel L Yung, MD         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Rachel L Yung, MD    206-606-7703    rlyung@seattlecca.org   
Principal Investigator: Rachel L Yung, MD         
Australia, Western Australia
St John of God Subiaco Hospital Recruiting
Perth, Western Australia, Australia, 6008
Contact: Joanne Youd    +61 8 6465 9204    joanne.youd@sjog.org.au;   
Principal Investigator: Christobel Saunders, MD         
Austria
Univ. Klinik f. Frauenheilkunde u. Geburtshilfe Recruiting
Graz, Austria, 8036
Contact: Vesna Bjelic-Radisic, MD    +43 316 385 80504    vesna.bjelic-radisic@medunigraz.at   
Principal Investigator: Vesna K Bjelic-Radisic, MD         
Univ. Klinik f. Frauenheilkunde Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Theresa Czech, MD    +43 512 504 23073    Theresa.Czech@i-med.ac.at   
Principal Investigator: Theresa Czech, MD         
LKH Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Prof MD    +43 5 2755 25800    r.greil@salk.at   
Principal Investigator: Richard Greil, Prof MD         
Med. Univ. Klinik f. Chir Recruiting
Vienna, Austria, 1090
Contact: Michael Gnant, MD    +43 1 40400 56460    michael.gnant@meduniwien.ac.at   
Principal Investigator: Michael Gnant, MD         
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Martine Berliere, MD    +32 2 764 1075    martine.berliere@uclouvain.be   
Principal Investigator: Martine Berliere, MD         
Cliniques Universitaires Saint-Luc Brussels Recruiting
Brussels, Belgium
Contact: Martine Berliere, MD    +32 2 764 1075    martine.berliere@uclouvain.be   
Principal Investigator: Martine Berliere, Prof         
Institut Jules Bordet Recruiting
Brussels, Belgium
Contact: Andrea Gombos    +32 2 541 7232    andrea.gombos@bordet.be   
Principal Investigator: Andrea Gombos         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant    +32 16 344 252    frederic.amant@uzleuven.be   
Principal Investigator: Frederic Amant         
C.H.U. Sart-Tilman Recruiting
Liege, Belgium, 4000
Contact: Guy Jerusalem    +32 43 668414    g.jerusalem@chu.ulg.ac.be   
Principal Investigator: Guy Jerusalem         
Clinique St.Elizabeth Recruiting
Namur, Belgium, 5000
Contact: Peter Vuylsteke    +32 81 720 547    peter.vuylsteke@cmsenamur.be   
Principal Investigator: Peter Vuylsteke         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Marc Webster, MD    +1 403 521 3093    marc.webster@albertahealthservices.ca   
Principal Investigator: Marc Webster, MD         
Canada, British Columbia
Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Karen Gelmon, MD    +1 604 877 6000 ext 2032    kgelmon@bccancer.bc.ca   
Principal Investigator: Karen Gelmon, MD         
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Christine Elser, MD    +1 416 946 3077    christine.elser@uhn.on.ca   
Principal Investigator: Christine Elser, MD         
Odette Cancer Centre - Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Ellen Warner, MD       ellen.warner@sunnybrook.ca   
Principal Investigator: Ellen Warner, MD         
Canada, Quebec
CHUM - Centre Hospitalier de l'Universite de Montreal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Andre Robidoux, MD    +1 514 890 8000 x14944    andre.robidoux.chum@ssss.gouv.qc.ca   
Principal Investigator: Andre Robidoux, MD         
CHA-Hopital Du St-Sacrement Recruiting
Quebec City, Quebec, Canada, G1S 4L8
Contact: Christine Desbiens, MD    +1 418 682 7511    christine.desbiens.cha@ssss.gouv.qc.ca   
Principal Investigator: Christine Desbiens, MD         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: Michel Pavic, MD    +1 819 346 1110 ext 74816    Michel.pavic@usherbrooke.ca   
Principal Investigator: Michel Pavic, MD         
Denmark
Rigshospitalet Not yet recruiting
København, Denmark, 2100
Contact: Ann Raaberg    +45 3866 0666    ar@dbcg.dk   
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Marc Debled, MD    +33 5 56 33 0477    m.debled@bordeaux.unicancer.fr   
Principal Investigator: Marc Debled, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Audrey Mailliez, MD    +33 3 20 29 5959    a-mailliez@o-lambret.fr   
Principal Investigator: Audrey Mailliez, MD         
French Lyon Cancer Center Recruiting
Lyon, France, 69373
Contact: Christine Rousset-Jablonski, MD    +33 4 78 78 2772    Christine.ROUSSET-JABLONSKI@lyon.unicancer.fr   
Principal Investigator: Christine Rousset-Jablonski, MD         
Greece
University General Hospital of Heraklion Recruiting
Stavrakia, Crete, Greece, 71110
Contact: Dimitris Mavroudis, MD    +30 281 039 2750    mavrudis@med.uoc.gr   
Principal Investigator: Dimitris Mavroudis, MD         
Laso General Hospital, First Department of Medical Oncology Not yet recruiting
Athens, Greece
Contact: Panagiotis Katsaounis       pvkatsaounis@gmail.com;   
Principal Investigator: Panagiotis Katsaounis, MD         
Hungary
University of Debrecen Medical and Health Science Centre Not yet recruiting
Debrecen, Hungary, 4032
Contact: Angéla Tóth    +36 52 255 840    toth.angela@med.unideb.hu;   
Principal Investigator: Zsolt Horváth, MD         
Debrecen University Dep. of Oncology Recruiting
Debrecen, Hungary
Contact: Zsolt Horvath, MD       horvathzsolt@med.unideb.hu   
Principal Investigator: Zsolt Horvath, MD         
Ireland
St. James's Hospital Recruiting
Dublin 8, Ireland
Contact: Jhon Kennedy, Prof    +353 01 425 4935    jkennedy@stjames.ie   
Principal Investigator: John Kenedy, Prof         
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Janice Walshe, MD    +353 01 414 2892    janice.walshe@amnch.ie   
Principal Investigator: Janice Walshe, MD         
Galway University Hospital Recruiting
Galway, Ireland
Contact: Maccon Keane, MD    +353 09 154 4805    maccon.keane@hse.ie   
Principal Investigator: Maccon Keane, MD         
University Hospital Limerick Recruiting
Limerick, Ireland
Contact: Linda Coate, MD       lindae.coate@hse.ie   
Principal Investigator: Linda Coate, MD         
University Hospital Waterford Recruiting
Waterford, Ireland
Contact: Miriam O'Connor, MD    +353 05 184 2020    miriam.oconnor@hse.ie   
Principal Investigator: Miriam O/Connor, MD         
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Shani Paluch-Shimon, Dr.    +972-2-5645435    shanips@szmc.org.il   
Principal Investigator: Shani Paluch-Shimon, Dr.         
Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 5265601
Contact: Bella Kaufman, MD    +972 3 530 2541    Bella.Kaufman@sheba.health.gov.il   
Principal Investigator: Bella Kaufman, MD         
Italy
U.O Medicina Oncologica Ospedale di Carpi Recruiting
Carpi, Modena, Italy, 41012
Contact: Fabrizio Artioli    +390 53 560 2528    f.artioli@ausl.mo.it   
Principal Investigator: Fabrizio Artioli         
Multimedica Spa Recruiting
Castellanza, Vareze, Italy
Contact: Luisa Molteni, MD    +390 331 393 272    luisapaola.molteni@multimedica.it   
Principal Investigator: Luisa Molteni, MD         
Centro di Riferimento Oncologico Recruiting
Aviano, Italy, 33081
Contact: Simon Spazzapan, MD    +390 434 659 024    spazzapan@cro.it   
Principal Investigator: Simon Spazzapan, MD         
Ospedale degli Infermi - S. C. Oncologia Medica Recruiting
Biella, Italy
Contact: Elena Seles    +390 15 1515 7503    seles.e@libero.it seles.e@libero.it   
Principal Investigator: Elena Seles         
Azienda Sanitaria di Bolzano Recruiting
Bolzano, Italy, 39100
Contact: Elisabetta Cretella    +390 471 908 572    elisabetta.cretella@sabes.it   
Principal Investigator: Elisabetta Cretella, MD         
Istituto Nazionale Ricerca Cancro Recruiting
Genova, Italy
Contact: Lucia Del Mastro, MD    +390 10 555 8908    lucia.delmastro@hsanmartino.it   
Principal Investigator: Lucia Del Mastro, MD         
Istituto scientifico Romagnolo per lo studio e la cura Recruiting
Meldola, Italy
Contact: Andrea Rocca, MD    +390 543 739 100    andrea.rocca@irst.emr.it   
Principal Investigator: Andrea Rocca         
Istituto Europeo di Oncologia (IEO) Recruiting
Milan, Italy, 20141
Contact: Claudia Sangalli    +390 257 489 934    claudia.sangalli@ieo.it;marco.colleoni@ieo.it   
Principal Investigator: Marco Colleoni         
University of Eastern Piedmont Recruiting
Novara, Italy, 28100
Contact: Alessandra Gennari, MD    +390 321 373 3984    alessandra.gennari@med.uniupo.it   
Principal Investigator: Alessandra Gennari, MD         
Istituti Clinici Scientifici Maugeri SpA-SB Recruiting
Pavia, Italy, 27100
Contact: Annalisa Lanza    +390 38 259 2669    antonio.bernardo@icsmaugeri.it   
Principal Investigator: Antonio Bernardo, MD         
Ospedale di Prato Recruiting
Prato, Italy
Contact: Marta Pestrin, MD    +390 574 802 531    marta.pestrin@uslcentro.toscana.it   
Principal Investigator: Marta Pestrin, MD         
UO Oncologia, Rimini Hospital Recruiting
Rimini, Italy, 47923
Contact: Lorenzo Gianni    +390 541 705 413    lgianni@auslrn.net   
Principal Investigator: Lorenzo Gianni, MD         
Regina Elena National Cancer Institute Recruiting
Rome, Italy
Contact: Patrizia Vici, MD    +390 652 666 646    patrizia.vici@ifo.gov.it   
Principal Investigator: Patrizia Vici, MD         
Ospedale di Trento Recruiting
Trento, Italy, 38122
Contact: Antonella Ferro, MD    +390 461 902 121    antonella.ferro@apss.tn.it   
Principal Investigator: Antonella Ferro, MD         
AO Universitaria Ospedale Di Circolo e Fondazione Recruiting
Varese, Italy, 21100
Contact: Graziella Pinotti, MD    +390 33 227 8558    graziella.pinotti@asst-settelaghi.it   
Principal Investigator: Graziella Pinotti, MD         
Japan
Kansai Rosai Hospital Recruiting
Amagasaki, Hyogo, Japan, 660-8511
Contact: Chiyomi Egawa, MD    +81 6 6416 1229    egawa-chiyomi@kansaih.johas.go.jp   
Principal Investigator: Chiyomi Egawa, MD         
Seirei Hamamatsu General Hospital Recruiting
Hamamatsu, Shizuoka, Japan
Contact: Masayuki Yoshida    +81-53-474-2222    myoshida@sis.seirei.or.jp   
Principal Investigator: Masayuki Yoshida         
NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi Recruiting
Fukuoka, Japan, 811-1395
Contact: Eriko Tokunaga, MD       tokunaga.e@nk-cc.gojp   
Principal Investigator: Eriko Tokunaga, MD         
Social Medical Corporation Hakuaikai Sagara Hospital Recruiting
Kagoshima, Japan
Contact: Junko Kawano    +81 99 224 1800    kawajun@sagara.or.jp   
Principal Investigator: Junko Kawano         
St Marianna University School of Medicine Hospital Recruiting
Kawasaki, Japan
Contact: Koichiro Tugawa, MD    +81 44 977 8111    koitsuga@marianna-u.ac.jp   
Principal Investigator: Koichiro Tugawa, MD         
Kyoto University Hospital Recruiting
Kyoto, Japan
Contact: Hiroshi Ishiguro    +81 75 751 4950    hkkishi@kuhp.kyoto-u.ac.jp;masa0123@kuhp.kyoto-u.ac.jp   
Contact    +81 75 751 3660      
Principal Investigator: Masahiro Kawashima, MD         
Toranomon Hospital Recruiting
Minato-ku, Tokyo, Japan, 105-8470
Contact: Hidetaka Kawabata, MD    +81 3 3588 1111    kawabata2000@gmail.com   
Principal Investigator: Hidetaka Kawabata, MD         
Kamiiida Daiichi General Hospital Recruiting
Nagoya, Japan, 463-0802
Contact: Yuko Okanami, MD    +81 52 991 3111    yokanami@yahoo.co.jp   
Principal Investigator: Tomoyuki Kubota, MD         
Okayama University Hospital Recruiting
Okayama, Japan
Contact: Tadahiko Shien    +81 86 235 7265    tshien@md.okayama-u.ac.jp   
Principal Investigator: Tadahiko Shien         
Tohoku University Hospital Recruiting
Sendai, Japan
Contact: Hiroshi Tada, MD    +81 22 717 7214    hiroshi-tada@med.tohoku.ac.jp   
Principal Investigator: Hiroshi Tada, MD         
National Cancer Center Hospital Recruiting
Tokyo, Japan
Contact: Chikako Shimizu    +81 3 3542 2511    cshimizu@ncc.go.jp   
Principal Investigator: Chikako Shimizu         
Showa University Hospital Recruiting
Tokyo, Japan
Contact: Seigo Nakamura, MD       seigonak@med.showa-u.ac.jp   
Principal Investigator: Seigo Nakamura, MD         
St Luke's International Hospital Recruiting
Tokyo, Japan
Contact: Hideko Yamauchi, MD    +81 3 3541 5151    hideyama@luke.ac.jp   
Principal Investigator: Hideko Yamauchi, MD         
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan
Contact: Akemi Kataoka, MD       akemi.kataoka@jfcr.or.jp   
Principal Investigator: Akemi Kataoka, MD         
University of Tsukuba Recruiting
Tsukuba, Japan
Contact: Hiriko Bando, MD    +81 29 853 3341    bando@md.tsukuba.ac.jp   
Principal Investigator: Hiriko Bando, MD         
NHO Osaka National Hospital Recruiting
Ōsaka, Japan
Contact: Norikazu Masuda, MD    +81 06 6942 1331    nmasuda@alpha.ocn.ne.jp   
Principal Investigator: Norikazu Masuda, MD         
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Jeong E Lee, MD       jeongeon.lee@samsung.com   
Principal Investigator: Jeong E Lee, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seock-Ah Im, MD    +82 2 2072 0850    moisa@snu.ac.kr   
Principal Investigator: Seock-Ah Im, MD         
Netherlands
Leiden University Medical Centre, Albinusdreef 2, Postbus 9600 Recruiting
Leiden, Netherlands, 2300 RC
Contact: Elise A van Leeuwen-Stok, PhD       e.vanleeuwen@boogstudycenter.nl   
Principal Investigator: Judith Kroep, MD         
Norway
Norwegian Radium Hospital (Oslo University) Recruiting
Oslo, Norway
Contact: Anna Saetersdal, MD    +47 22 934 000    asd@ous-hf.no   
Principal Investigator: Anna Saetersdal, MD         
Portugal
Champalimaud Cancer Center - Breast Cancer Unit Recruiting
Lisbon, Portugal
Contact: Fatima Cardoso    +35 1 210 480 048    fatimacardoso@fundacaochampalimaud.pt   
Principal Investigator: Fatima Cardoso         
Serbia
Institute of Oncology & Radiology of Serbia Recruiting
Belgrade, Serbia
Contact: Snezana Susnjar, MD    +381 64 151 5721    suska.sule@gmail.com   
Principal Investigator: Snezana Susnjar, MD         
Slovenia
Institute of Oncology Ljubljana - Medical Oncology Department Recruiting
Ljubljana, Slovenia
Contact: Simona Borstnar    +386 1 58 79 976    sborstnar@onko-i.si   
Principal Investigator: Simona Borstnar         
Spain
Hospital Clinico Universitario Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain
Contact: Pilar Sanchez Henarejos    +34 96 836 9516    sanchezhenarejos@gmail.com   
Principal Investigator: Pilar Sanchez Henarejos, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Cristina Saura    +34 93 489 4350    csaura@vhio.net   
Principal Investigator: Sandra Porta, MD         
Hospital General de Catalunya Recruiting
Barcelona, Spain
Contact: Xavier Gonzalez, MD    +34 93 565 6000    xgonzalez@oncorosell.com   
Principal Investigator: Xavier Gonzalez, MD         
Instituto Catalán de Oncología de Gerona Hospital Recruiting
Gerona, Spain
Contact: Sonia Del Barco, MD    +34 972 225 828    sdelbarco@iconcologia.net   
Principal Investigator: Sonia Del Barco, MD         
Centro Integral Oncologico Clara Campal (CIOCC) Recruiting
Madrid, Spain
Contact: Isabel Calvo Plaza    +34 917 56 7984    icalvoplaza@hmhospitales.com   
Principal Investigator: Isabel Calvo Plaza         
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Jose A Garcia-Saenz, MD    +34 91 330 3000 ext 7768    jagsaenz@yahoo.com   
Principal Investigator: Jose A Garcia-Saenz, MD         
Hospital Universitario de Fuenlabrada Recruiting
Madrid, Spain
Contact: Juan Guerra, MD    +34 91 600 6584    juanantonio.guerra@salud.madrid.org   
Principal Investigator: Juan Guerra, MD         
Hospital Clinico Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: Maria J Bermejo, MD    +34 652 319 926    cheberpe@gmail.com   
Principal Investigator: Maria J Bermejo, MD         
Hospital Son Espases, Palma de Mallorca Recruiting
Palma, Spain
Contact: Antonia Perello    +34 871 206 130    antonia.perellom@ssib.es   
Principal Investigator: Antonia Perello         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Contact: José J Illarramendi, MD    +34 848 421 554    researcherillarramendi@gmail.com   
Principal Investigator: José J Illarramendi, MD         
Complejo Hospitalario Universitario de Santiago Recruiting
Santiago de Compostela, Spain
Contact: Rafael Lopez    +34 98 195 1471    rafael.lopez.lopez@sergas.es   
Principal Investigator: Rafael Lopez         
Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Manuel R Borrego, MD    +34 955013068    ruizborrego@gmail.com   
Principal Investigator: Manuel R Borrego, MD         
Hospital Quiron Sagrado Corazon Recruiting
Sevilla, Spain
Contact: Juan A Virizuela, MD    +34 95 493 7676    javirizuelae@seom.org   
Principal Investigator: Juan A Virizuela, MD         
Hospital General Universitario de Valencia - Servico Oncologia Recruiting
Valencia, Spain
Contact: Vega Iranzo    +34963131 ext 43765    iranzo_veg@gva.es   
Principal Investigator: Vega Iranzo         
Hospital Clinico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Raquel Andrés, MD    +34976765746    randresc@salud.aragon.es   
Principal Investigator: Raquel Andrés, MD         
Switzerland
Spital STS AG Onkologiezentrum Thun-Berner Oberland Recruiting
Thun, Bern, Switzerland, 3600
Contact: Daniel Rauch    +41 58 636 2645    daniel.rauch@spitalstag.ch   
Principal Investigator: Daniel Rauch         
Kantonspital Baden AG Recruiting
Baden, Switzerland, 5404
Contact: Cornelia Leo    +41 56 48 63 514    cornelia.leo@ksb.ch   
Principal Investigator: Cornelia Leo         
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Marcus Vetter    +41 61 328 75 38    Marcus.Vetter@usb.ch   
Principal Investigator: Marcus Vetter         
Istituto Oncologico della Svizzera Italiana (IOSI) Recruiting
Bellinzona, Switzerland
Contact: Olivia Pagani    +41 79 208 7785    olivia.pagani@ibcsg.org   
Principal Investigator: Olivia Pagani         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Manuela Rabaglio    +41 31 632 43 70    manuela.rabaglio@insel.ch   
Principal Investigator: Manuela Rabaglio         
Oncocare Bern Recruiting
Bern, Switzerland, 3012
Contact: Marcus Borner, MD    +41 31 309 95 01    markus.borner@lindenhofgruppe.ch   
Principal Investigator: Marcus Borner, Prof         
Brustzentrum Thurgau - Obstetrics and Gynecology Recruiting
Frauenfeld, Switzerland
Contact: Mathias Fehr    +41 52 723 7255    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr         
University Hospital Geneva Recruiting
Genève, Switzerland, 1211
Contact: Alexandre Bodmer    +41 22 382 4014    alexandre.bodmer@hcuge.ch   
Principal Investigator: Alexandre Bodmer         
University Hospital of Lausanne (CHUV) BH06 - Oncology Department Recruiting
Lausanne, Switzerland
Contact: Khalil Zaman    +41 79 556 7801    khalil.zaman@chuv.ch   
Principal Investigator: Khalil Zaman         
CHCVs Hôpital de Sion Recruiting
Sion, Switzerland, 736
Contact: Veronique Membrez    +41 27 603 8948    veronique.membrez@hopitalvs.ch   
Principal Investigator: Veronique Membrez         
Brustzentum Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Salome Riniker    +41714941111    salome.riniker@kssg.ch   
Principal Investigator: Salome Riniker         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Konstantin Dedes    +41 44 255 5200    konstantin.dedes@usz.ch   
Principal Investigator: Konstantin Dedes, MD         
Brust-Zentrum AG Recruiting
Zürich, Switzerland, 8008
Contact: Christoph Tausch    +41 44 380 7660    c.tausch@brust-zentrum.ch   
Principal Investigator: Christoph Tausch, MD         
Sponsors and Collaborators
International Breast Cancer Study Group
Alliance for Clinical Trials in Oncology
Canadian Cancer Trials Group
Breast International Group
Investigators
Layout table for investigator information
Study Chair: Olivia Pagani, MD Oncology Institue of Southern Switzerland (IOSI)

Publications:
Layout table for additonal information
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT02308085     History of Changes
Other Study ID Numbers: IBCSG 48-14 / BIG 8-13
Alliance A221405 ( Other Identifier: Alliance for Clinical Trials in Oncology )
NCIC CTG MAC.18 ( Other Identifier: NCIC Clinical Trials Group )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Keywords provided by International Breast Cancer Study Group:
Premenopausal
endocrine responsive
Breast
Pregnancy

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases