- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823654
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shari Goldfarb, MD
- Phone Number: 646-888-5080
Study Contact Backup
- Name: Kimberly Van Zee, MD
- Phone Number: 646-888-5362
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States
- Recruiting
- Memorial Sloan Kettering Basking Ridge
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
Contact:
- Kimberly Van Zee, MD
- Phone Number: 646-888-5362
-
Principal Investigator:
- Shari Goldfarb, MD
-
New York, New York, United States, 10065
- Active, not recruiting
- New York Presbyterian Hospital-Weill Medical College of Cornell University
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau
-
Contact:
- Shari Goldfarb, MD
- Phone Number: 646-888-5080
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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 Yale Medicine.
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.
Description
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.
- Have regular menstrual cycles; patients can have no more than 1 irregular cycle (too early or too late) within the past year or were pregnant in the past 12 months, 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 25-45 with known BRCA mutations
- 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.
Subject Inclusion:
For affected BRCA1 and BRCA2 mutation carriers, affected women with non-BRCA mutations, and BC patients with no mutations (control)
- Premenopausal women age 21-45 with stage 0-3 breast cancer
- No prior ovarian surgery or ovarian disease
- No prior chemotherapy
- Regular menstrual periods (21-35 days), no PCOS
- No hormonal contraception within the prior 4 weeks
- Mutation testing decision based on NCCN Guidelines V1.2021: according to these Guidelines, both centers test all pre-menopausal women with breast cancer for BRCA and non-BRCA mutations which are the subject of this proposal
- Receiving an anthracycline (typically doxo/Adriamycin) and Cy (AC)-based chemotherapy protocol
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 Subject Exclusion Criteria For affected BRCA1 and BRCA2 mutation carriers, affected women with non-BRCA mutations, and BC patients with no mutations (control)
- Subjects who did not undergo mutation testing, as well as those who tested positive for more than one family (BRCA1, BRCA2, non-BRCA) of ATM-Pathway gene mutations, will be excluded.
- Women aged >42 years will be excluded as they carry a very high probability of chemotherapy-induced OI49. It is important to select an age range where immediate OI is less likely to occur because if most women become menopausal post-chemotherapy, the comparison of ovarian reserve decline will not be feasible.
- In our prior grant period, we showed that the AC-based and CMF regimens similarly compromise ovarian reserve (Fig. 1)9 Currently, the AC-based chemotherapy is utilized in >90% breast ca cases, and CMF protocol is rarely administered9. For this reason and to enhance uniformity, rare non-AC-based protocols will be excluded.
- A previous study showed that smoking and BRCA mutations may have additive negative effects on the age of menopause27, consequently, we will exclude current smokers (smoked 100 cigarettes lifetime and currently smokes, per CDC). Based on our past studies6,9, the smoking incidence is low in our study population (<20%) and should not significantly limit accrual.
- BMI: In our recent publication9 (Fig. 1), the mean BMI was 24.22 ±0.4 (median 23.2; range 17-42); hence the extreme BMI values are rare in our population. Nevertheless, those with BMI of <18.5 and >40 will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Premenopausal Women with Early Stage Breast Cancer
|
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 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 ↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires ↓ Optional annual follow-up years 2-5 Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires |
Unaffected High Risk Women with BRCA mutations
|
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 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 ↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires ↓ Optional annual follow-up years 2-5 Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: 2 years
|
in premenopausal breast cancer patients & to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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: 2 years
|
2 years
|
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: 2 years
|
2 years
|
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: 2 years
|
2 years
|
To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women.
Time Frame: 2 years
|
2 years
|
To study sexual health and function in unaffected high risk BRCA mutation carriers
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shari Goldfarb, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Blood draw and questionnaires
-
Memorial Sloan Kettering Cancer CenterCompletedLung Cancer | Single Primary Lung Cancer | Second Primary Lung CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Alaunos Therapeutics; National Center for Research...RecruitingRetroviridae Infections | CancerUnited States
-
University of Southern CaliforniaStanford UniversityCompletedHereditary Breast and Ovarian CancerUnited States
-
Washington University School of MedicineTemple UniversityRecruiting
-
Boston Medical CenterNational Institute on Drug Abuse (NIDA)CompletedSmoking | HIVUnited States
-
University Hospitals Cleveland Medical CenterCellPrint BiotechnologyTerminatedBipolar DisorderUnited States
-
Vanderbilt UniversityActive, not recruitingPostural Orthostatic Tachycardia SyndromeUnited States
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI); National Institute on Aging...CompletedPain | Total Hip Replacement | Metallosis | Total Knee ReplacementUnited States
-
Abbott Point of CareNot yet recruitingPrecision of Potassium (K) Test in Capillary Whole Blood