Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
New York Medical College
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00823654
First received: January 14, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer treatment can make it hard for a person to conceive a child in the future. It may also bring on early menopause. We will check blood levels of hormones that the ovaries produce. We will do this before, during, and after the cancer treatment. We will also ask the patient to fill out questionnaires about their menstrual cycle (periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.


Condition Intervention
Breast Cancer
Other: Blood draw and questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer BRCA Mutations

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned) [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
    in premenopausal breast cancer patients & to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.


Secondary Outcome Measures:
  • To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To describe the impact of commonly used therapies for early-stage breast cancer on self-reported monthly menstrual cycles and future pregnancy/reproductive health. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To study sexual health and function in unaffected high risk BRCA mutation carriers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 320
Study Start Date: January 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Premenopausal Women with Early Stage Breast Cancer Other: Blood draw and questionnaires

At the start of the study: blood draw, questionnaire and menstrual calendar ↓ Start planned therapy (or observation/surveillance) for cancer treatment

Tests in the middle of chemotherapy (if applicable):

Blood draw and collection of monthly menstrual calendars ↓

Tests when chemotherapy is over (if applicable):

Blood draw and collection of monthly menstrual calendars

Tests every 4 months for about 1 year:

Blood draw, collection of monthly menstrual calendars, and questionnaire ↓

Tests every 6 months for about 1 year:

Blood draw, collection of monthly menstrual calendars, and questionnaire

Yearly follow-up for about 2 years:

Blood draw collection of monthly menstrual calendars, and questionnaire

Unaffected High Risk Women with BRCA mutations Other: Blood draw and questionnaires

Study Schema for Unaffected High Risk Women with BRCA mutations Identify eligible premenopausal patients and obtain informed consent

↓ Register patients at Memorial Sloan-Kettering Cancer Center

↓ Baseline evaluation: Blood draw and baseline reproductive health and sexual questionnaires (Appendix A)/menstrual calendar (Appendix C)

↓ Annual follow-up x 4 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health and sexual health questionnaires


  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of premenopausal women with early-stage breast cancer will be recruited from the Breast Cancer Service at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell University. In addition, breast cancer patients seeking consultation with a reproductive endocrinologist to address issues of fertility preservation prior to the start of therapy will be offered participation (Dr. Oktay at New York Medical College.

Patients of unaffected high risk premenopausal women with BRCA mutations will be recruited from the Breast Cancer Services especially the high risk surveillance clinics at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell Univeristy.

Criteria

Inclusion Criteria:

For Premenopausal Women with Early Stage Breast Cancer

  • Premenopausal female patients age 18-44 with breast cancer as defined as:

    a. AJCC Stage 0-III breast cancer, regardless of hormone-receptor status or HER2-overexpression, before the start of planned adjuvant or neoadjuvant chemotherapy and/or hormonal therapy. If chemotherapy is planned, the regimen must be either CMF, anthracycline containing, or taxane containing. If hormonal therapy is planned, the regimen must be limited to tamoxifen. All biologics (e.g. bevacizumab, trastuzumab, lapatinib, etc.) are allowed in addition to the above therapies.

  • ECOG performance status 0-1
  • Have regular menstrual cycles; patients can have no more than 1 irregular cycle (too early or too late) within the past year and/or at least 10 spontaneous cycles within the past year.

Subject Inclusion:

For Unaffected High Risk Premenopausal Women with BRCA mutations

  • Premenopausal Women ages 30-45 with known BRCA mutations
  • ECOG performance status 0-1
  • Have regular menstrual (21-35 days); patients can have no more than 1 irregular cycle (too early or too late) within the past year and/or at least 10 spontaneous cycles within the past year.
  • No history of breast or ovary cancer.

Exclusion Criteria:

For Cohort of Premenopausal Women with Early Stage Breast Cancer

  • Prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.
  • Ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
  • Plans for risk-reducing bilateral oophorectomy within one year of completion of chemotherapy.
  • Prior known infertility; infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.
  • Family history of a first-degree relative with non-surgical menopause < age 40
  • Current pregnancy.

Subject Exclusion Criteria:

For Unaffected High Risk Premenopausal Women with BRCA mutation

  • Prior chemotherapy or immunotherapy for breast cancer or any other cancer
  • Ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region or ovarian disease (e.g. polycystic ovarian syndrome).
  • Plans for risk-reducing bilateral oophorectomy within one year
  • Prior known infertility; (except women who have undergone voluntary tubal ligation); infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.
  • Family history of a first-degree relative with non-surgical menopause < age 40
  • Current pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823654

Contacts
Contact: Maura Dickler, MD 646-888-4560
Contact: Kimberly Van Zee, MD 646-888-5362

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Maura Dickler, MD    646-888-4560      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Maura Dickler, MD    646-888-4560      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maura Dickler, MD    646-888-4560      
Contact: Kimberly Van Zee, MD    646-888-5362      
Principal Investigator: Maura Dickler, MD         
New York Presbyterian Hospital-Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Tessa Cigler, MD         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Maura Dickler, MD    646-888-4560      
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital Recruiting
Sleepy Hollow, New York, United States
Contact: Maura Dickler, MD    646-888-4560      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Medical College
New York Presbyterian Hospital
Weill Medical College of Cornell University
Investigators
Principal Investigator: Maura Dickler, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00823654     History of Changes
Other Study ID Numbers: 08-156
Study First Received: January 14, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Questionaires
Blood draw
BRCA1
BRCA2
08-156

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014