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A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer (LUMINA)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01791829
First received: February 12, 2013
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women postulated to be at low risk for recurrence. Women with luminal A breast cancer determined by immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated with endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be treated with breast irradiation (BI). Subjects will be followed for 10 years and will be assessed for recurrent disease, new primary cancer and survival.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Ipsilateral Breast Tumour Recurrence (IBTR) [ Time Frame: 5 years ]
    The primary outcome is IBTR defined as recurrent invasive or in-situ cancer in the ipsilateral breast during follow-up. Histological evidence of recurrence will be required. All recurrences will be reviewed by a central adjudication committee.


Secondary Outcome Measures:
  • Recurrence Free interval (RFI) [ Time Frame: 5 years ]
    Recurrence free interval (RFI) defined as time from registration to time of documented recurrent disease (ipsilateral breast, regional or distant)

  • Event-free survival (EFS) [ Time Frame: 5 years ]
    Event-free survival (EFS) defined as the time from registration to the time of documented IBTR, regional (ipsilateral axilla, supraclavicular or internal mammary nodes), distant recurrence (bone, liver, lung, brain, etc.), contralateral breast cancer, new primary cancer or death

  • Overall survival (OS) [ Time Frame: 5 years ]
    Overall survival (OS) defined as time from registration to death of any cause


Biospecimen Retention:   Samples With DNA
Specimens will be used to determine Ki67 status by IHC and subsequent testing for DNA/RNA.

Estimated Enrollment: 500
Study Start Date: July 2013
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
Luminal A with other Clinical Criteria
BCS postulated to be at low risk for IBTR following Endocrine Therapy

Detailed Description:

The independent prognostic ability of the luminal A subtype has been demonstrated in two retrospective analyses of prospective trials and suggests that luminal A combined with other known clinical prognostic factors could be used to select patients treated with BCS at very low risk for IBTR who could avoid BI. Given that using intrinsic subtyping combined with other clinical factors to identify women who could avoid BI would be a major change in clinical practice, we propose that a prospective study is necessary to confirm that such an approach can accurately identify a group of women at very low risk for IBTR following BCS.

We anticipate that the risk of IBTR in the low risk group is likely to be lower than that observed in previous trials (predicted to be < 5% at 5 years and < 10% at 10 years) for several reasons: first, our selection criteria (node negative, luminal A, > or = 55 years, tumours < or = 2cm, excision margin > or = 1mm post-BCS, absence of lobular cancers, extensive intraductal component and lymphovascular invasion) are more restrictive than in previous trials and second, the risks of IBTR are steadily decreasing over time due to improvements in mammographic screening, pre-op staging, tumour localization, and surgical practice. The expected low failure rates are unlikely to warrant the use of radiation.

A prospective cohort study was identified as the most appropriate and efficient design as our primary hypothesis is that a group of patients at very low risk of IBTR can be identified. A randomized trial could address the effectiveness of radiation in such a cohort of patients, but would require a much larger sample size to detect very small differences, which would not be clinically meaningful. During the conduct of this trial it is anticipated that patients who do not meet study criteria or who decline study enrollment, will continue to receive BI after BCS.

  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a multicentre, single-arm prospective cohort study evaluating risk of IBTR following BCS in a group of women postulated to be at low risk for recurrence. Subjects will be followed for 10 years and will be assessed for recurrent disease, new primary cancer and survival. The primary outcome is IBTR
Criteria

Inclusion Criteria:

  1. Female patient > or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour < or =2cm on microscopic exam, with no evidence of metastatic disease;
  2. ER positive (> or =1%) and PR positive (>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
  3. Treated by BCS with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
  4. Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.

Exclusion Criteria:

  1. Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
  2. Multifocal or multicentric disease.
  3. Evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of DCIS and the DCIS extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
  4. Grade 3 histology for invasive disease
  5. Evidence of lymphovascular invasion.
  6. Evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
  7. Bilateral malignancy of the breast (synchronous or metachronous).
  8. Known BRCA 1 or 2 mutations.
  9. History of non-breast cancer malignancies if not disease free for > 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
  10. Serious non-malignant disease associated with a life expectancy < 10 years.
  11. Inability to be treated with or to tolerate endocrine therapy.
  12. Psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
  13. Geographic inaccessibility for follow-up.
  14. Inability to understand or unable to provide written informed consent.
  15. Inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
  16. Central testing for Ki67 > 13.25% consistent with the luminal B subtype
  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: NCT01791829

Contacts
Contact: Luciana Spadafora 905-527-2299 ext 42655 spadafl@mcmaster.ca
Contact: Sharon Nason 905-527-2299 ext 42622 nasons@mcmaster.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Tien Phan, M.D.    403-521-3071    tien.phan@albertahealthservices.ca   
Contact: Shirlee McKinnon    403-521-3621    shirlee.mckinnon@albertahealthservices.ca   
Principal Investigator: Tien Phan, M.D,         
Canada, British Columbia
Abbotsford Centre Recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
Contact: Beverly H Lester, M.D.    604-851-4710 ext 645302    blester@bccancer.bc.ca   
Contact: Cathy Jackson    604-851-4710 ext 645274    cjackson@bccancer.bc.ca   
Sub-Investigator: Maha Almahmudi, MD         
Principal Investigator: Beverly H Lester, MD         
Sub-Investigator: Anagha Gurjal, MD         
Sub-Investigator: Asif Shaikh, MD         
Sub-Investigator: Wen W Shan, MD         
Sub-Investigator: Dorothy L Uhlman, MD         
BC Cancer Agency, Centre for the North Recruiting
Prince George, British Columbia, Canada, V2M 7E9
Contact: Robert Olson, M.D.    250-645-7325    rolson2@bccancer.bc.ca   
Contact: Alice Muirhead    250-645-7300 ext 687522    alice.muirhead@bccancer.bc.ca   
Principal Investigator: Robert Olson, M.D.         
Sub-Investigator: Stacy Miller, M.D.         
Sub-Investigator: Boris Valev, M.D.         
BCCA - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: David Vodcu, M.D.    604-877-6000 ext 2672    dvoduc@bccancer.bc.ca   
Contact: Sunshine Purification    604-877-6000 ext 2683    sunshine.purificacion@bccancer.bc.ca   
Sub-Investigator: Hannah M Carolan, M.D.         
Sub-Investigator: Mohamed Khan, MD         
Sub-Investigator: Peter Lim, MD         
Principal Investigator: David Voduc, MD         
Sub-Investigator: Alan M Nichol, MD         
Sub-Investigator: Torsten Nielsen, MD         
Sub-Investigator: Christina A Parsons, MD         
Sub-Investigator: Lorna M Weir, MD         
BC Cancer Agency Recruiting
Victoria, British Columbia, Canada, V9R 6V5
Principal Investigator: Sally Smith, MD         
Sub-Investigator: Tanya Berrang         
Sub-Investigator: Pauline Truong         
Sub-Investigator: Isabelle Vallieres         
Sub-Investigator: Elaine S Wai         
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Mohamed Akra, M.D.    204-787-1210    makra1@cancercare.mb.ca   
Contact: Raquel Gamez    204-787-4513    rgamez@cancercare.mb.ca   
Principal Investigator: Mohamed Akra, M.D.         
Sub-Investigator: Andrew Cooke, M.D.         
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Christiaan Stevens, M.D.    705-728-9090    stevensc@rvh.on.ca   
Contact: Kim Marsh-Gray    705-728-9090 ext 43340    marshk@rvh.on.ca   
Sub-Investigator: Mathew J Follwell, M.D.         
Sub-Investigator: Tiffany Tam, M.D.         
Principal Investigator: Christiaan Stevens, M.D.         
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Tim Whelan, MD    905-387-9711 ext 64501    tim.whelan@jcc.hhsc.ca   
Principal Investigator: Tim Whelan, MD         
Sub-Investigator: Ian S Dayes         
Sub-Investigator: Iwa Kong         
Sub-Investigator: Harold Reiter         
Sub-Investigator: Barbara K Strang         
Sub-Investigator: James R Wright         
Cancer Centre of Southern Ontario at Kingston Recruiting
Kingston, Ontario, Canada
Contact: Conrad Falkson, MD    613-549-6666 ext 4509    conrad.falkson@krcc.on.ca   
Contact: Christine L Maize, BSc.    613-549-6666 ext 6611    christine.maize@krcc.on.ca   
Principal Investigator: Conrad Falkson, MD         
Sub-Investigator: Kishore S Thain         
Sub-Investigator: William MacKillop         
Sub-Investigator: Ellen C de Metz         
Grand River Regional Cancer Centre Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Ramana M Rachakonda, M.D.    519-749-4300 ext 5489    ramana.rachakonda@grhosp.on.ca   
Contact: Kristin Krokoszynski    519-749-4370 ext 2664    kristin.krokoszynski@grhosp.on.ca   
Principal Investigator: Ramana M Rachakonda, M.D.         
Sub-Investigator: Darin Gopaul, M.D.         
Sub-Investigator: Vasanth Basrur, M.D.         
Sub-Investigator: Sofya Kobeleva, M.D.         
Sub-Investigator: Joda Kuk, M.D.         
Sub-Investigator: Sundeep Shahi         
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Francisco Perera, M.D.    519-685-8650    francisco.perera@lhsc.on.ca   
Contact: Jennifer Hare    519-685-8618    jennifer.hare@lhsc.on.ca   
Principal Investigator: Francisco Perera, M.D.         
Sub-Investigator: David D'Souza, M.D         
Sub-Investigator: Michael I Lock, M.D.         
Sub-Investigator: Nancy Read, M.D.         
Sub-Investigator: Tracy Sexton, M.D.         
Sub-Investigator: Olga Vujovic, M.D.         
Sub-Investigator: Brian Yaremko, M.D.         
Sub-Investigator: Edward Yu, M.D.         
R.S. McLaughlin Durham Regional Cancer Centre Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Wayne Koll, M.D.    905-576-8711 ext 3815    akoll@lakeridgehealth.on.ca   
Contact: Edeliza Mendoza, BSc,    905-576-8711 ext 4297    emendoza@lakeridgehealth.on.ca   
Principal Investigator: Wayne Koll, M.D         
Sub-Investigator: Behzad Banihashemi         
Sub-Investigator: Frederick P Dixon         
Sub-Investigator: Medhat El-Mallah         
Sub-Investigator: Orit Freedman         
Sub-Investigator: Fawaad Iqbal         
Sub-Investigator: Audrey WY Li         
Sub-Investigator: Jimmy Mui         
Sub-Investigator: Donald S Myrehaug         
Ottawa Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Laval Grimard, M.D.    613-737-7700 ext 70196    lgrimard@ottawahospital.on.ca   
Contact: Patricia L Spencer    613-737-7700 ext 70304    pspencer@toh.on.ca   
Principal Investigator: Laval Grimard, MD         
Sub-Investigator: Mark Clemons, MD         
Sub-Investigator: Peter Cross, MD         
Sub-Investigator: Sammy El-Sayed, MD         
Sub-Investigator: Catherine Lochrin, MD         
Sub-Investigator: Joanne Meng, MD         
Sub-Investigator: Scott C Morgan, MD         
Sub-Investigator: Xinni Song, MD         
Sub-Investigator: Paul Wheatley-Price, MD         
Algoma District Cancer Program Recruiting
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Contact: Silvana Spadafora, M.D.    705 759 3434 ext 4450    spadaforas@sah.on.ca   
Contact: Natalie Kovacevich    705 759 3434 ext 4402    kovacevichn@sah.on.ca   
Sub-Investigator: Julie Bowen, M.D.         
Sub-Investigator: Andrew Pearce, M.D.         
Sub-Investigator: Mohammad Rassouli, M.D.         
Sub-Investigator: Ioannis Voutsadakis, M.D.         
Niagara Health System Recruiting
St. Catharines, Ontario, Canada, L2S 0A9
Contact: Abhirami Hallock, M.D.    905-684-7271 ext 43801    hallock@hhsc.ca   
Contact: Linda Illes    905-684-7271 ext 43801    Linda.Illes@niagarahealth.on.ca   
Principal Investigator: Abhirami Hallock, M.D.         
Sub-Investigator: Brian Findlay, M.D.         
Sub-Investigator: Janet Giesbrecht, M.D.         
Sub-Investigator: Philip Hughes, M.D.         
Sub-Investigator: Kim Do-Hoon, M.D.         
Sub-Investigator: Linda Lee, M.D.         
Sub-Investigator: Michael Levesque, M.D.         
Sub-Investigator: William McMilllan, M.D.         
Sub-Investigator: Gordon Okawara, M.D.         
Sub-Investigator: Rachel Vandermeer, M.D.         
Sub-Investigator: David W Wasserman, M.D.         
Sub-Investigator: Radhika Yelamanchili, M.D.         
Northeastern Ontario Regional Cancer Centre Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Julie Bowen, M.D.    705-522-6237 ext 2451    jbowen@hsnsudbury.ca   
Contact: Catherine M Simeoni    705-522-6237 ext 2400    csimeoni@hsnsudbury.ca   
Principal Investigator: Julie Bowen, M.D.         
Sub-Investigator: David A Want, M.D.         
Sub-Investigator: Sarwat Shehata, M.D.         
Thunder Bay Regional Health Sciences Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Margaret L Anthes, MD    807-684-7200    anthesm@tbh.net   
Contact: Brad Leishman    807-684-7226    leishmab@tbh.net   
Principal Investigator: Margaret L Anthes, MD         
Sub-Investigator: Amir Hossein Faghih, MD         
Sub-Investigator: Kevin Ramchandar, MD         
Sub-Investigator: Dolores A Sicheri, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Eileen Rakovitch, M.D.    416-480-4974    eileen.rakovitch@sunnybrook.ca   
Contact: Carolyn Lim    416-480-5000 ext 7219    Carolyn.Lim@sunnybrook.ca   
Principal Investigator: Eileen Rakovitch, M.D.         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z6
Contact: Anthony W Fyles, M.D.    416-946-6522    anthony.fyles@rmp.uhn.on.ca   
Contact: Lea M. Dungao    416-946-4501 ext 2589    lea.dungao@rmp.uhn.on.ca   
Principal Investigator: Anthony W Fyles, M.D.         
Sub-Investigator: Kathy Han, M.D.         
Sub-Investigator: Fei-Fei Liu, M.D.         
Canada, Quebec
Centre integre de sante et de services sociaux de laval (CISSS de Laval) Recruiting
Laval, Quebec, Canada, H7M 3L9
Contact: Gary Mok, M.D.    450-668-1010 ext 23090    gmok.csssl@ssss.gouv.qc.ca   
Contact: Solange Tremblay    450-668-1010 ext 23603    stremblay.csssl@ssss.gouv.qc.ca   
Principal Investigator: Gary Mok, M.D.         
CHUM - Hopital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Sophie Lavertu, M.D.    5148908254    sophie.lavertu.chum@ssss.gouv.qc.ca   
Contact: Diane Trudeau    5148908000 ext 26906    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Sub-Investigator: Pierre Del-Vecchio, M.D.         
Principal Investigator: Sophie Lavertu, M.D.         
Sub-Investigator: Jean-Pierre Guay, M.D.         
Sub-Investigator: Erica Patocskai, M.D.         
Sub-Investigator: Andre Robidoux, M.D.         
Sub-Investigator: Pierre Rousseau, M.D.         
Sub-Investigator: Toni Vu, M.D.         
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Thierry M Muanza, M.D.    514-340-8288    tmuanza@jgh.mcgill.ca   
Contact: Karen Lai Wing Sun    514-340-8222 ext 5098    klaiwingsun@jgh.mcgill.ca   
Principal Investigator: Thierry M Muanza, M.D.         
Sub-Investigator: Khalil Sultanem, M.D.         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Tarek Hijal, M.D.    514-934-4400    tarek.hijal@muhc.mcgill.ca   
Contact: Pascale Brisebois    514-934-1934 ext 43186    pascale.brisebois@muhc.mcgill.ca   
Principal Investigator: Tarek Hijal, M.D.         
Sub-Investigator: Valerie Panet-Raymond, M.D.         
Sub-Investigator: Marc David, M.D.         
Sub-Investigator: Christine Lambert, M.D.         
Sub-Investigator: Bassam Abdulkarim, M.D.         
CHUQ - Pavillon Hotel-Dieu de Quebec Recruiting
Quebec city, Quebec, Canada, G1R 2J6
Contact: Valerie Theberge, M.D.    418-691-5264    valerie.theberge@mail.chuq.qc.ca   
Contact: Josee Allard    418-691-5264    Josee.Allard@chudequebec.ca   
Sub-Investigator: Anne Dagnault, M.D.         
Principal Investigator: Valerie Theberge, M.D.         
Sub-Investigator: Melanie Gaudreault, M.D.         
Sub-Investigator: Isabelle Germain, M.D.         
Sub-Investigator: Nathalie Lessard, M.D.         
CHUS - Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Sawyna Provencher, M.D.    8193461110 ext 16238    sawyna.provencher@usherbrooke.ca   
Contact: Sophie Couture, R.N.    8193461110 ext 14311    socouture.chus@ssss.gouv.qc.ca   
Principal Investigator: Sawyna Provencher, M.D.         
Sub-Investigator: Rachel Bujold, M.D.         
Sub-Investigator: Isabelle Gauthier, M.D.         
Sub-Investigator: Laurence Masson-cote, M.D.         
Canada, Saskatchewan
The Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Wendie Templeton    306-766-2488    wendie.templeton@saskcancer.ca   
Contact: Shazia Mahmood, M.D.    306-766-2296    shazia.mahmood@saskcancer.ca   
Principal Investigator: Shazia Mahmood, M.D.         
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Philip Wright, MD    3066552740    philip.wright@saskcancer.ca   
Contact: Frances Glover    3066552667    frances.glover@saskcancer.ca   
Principal Investigator: Philip Wright, M.D.         
Sub-Investigator: Ali El-Gayed, M.D.         
Sub-Investigator: vijayananda Kundapur, M.D.         
Sub-Investigator: Duc Le, M.D.         
Sub-Investigator: Moftah Younis, M.D.         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
British Columbia Cancer Agency
Investigators
Principal Investigator: Tim Whelan, MD Ontario Clinical Oncology Group (OCOG)
Principal Investigator: Sally Smith, MD British Columbia Cancer Agency (BCCA)
  More Information

Additional Information:
Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01791829     History of Changes
Other Study ID Numbers: OCOG-2012-LUMINA
Study First Received: February 12, 2013
Last Updated: April 3, 2017

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Luminal A
Ipsilateral Breast Tumour Recurrence

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on June 22, 2017