Breast CancerNCT00823654
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood draw and questionnaires
- How many people
- 609 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2009to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- For Premenopausal Women with Early Stage Breast Cancer
- Participant is between 18-44 years old.
- Participant is premenopausal.
- Participant is female.
- Participant has a known breast cancer diagnosis of 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.
- The chemotherapy regimen must be either CMF, anthracycline-containing, or taxane-containing. If hormonal therapy is planned, the regimen must be limited to tamoxifen All biologics are allowed in addition to the above therapies.
Show all 17Show fewer
- The participant has regular menstrual cycles; note: 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. Exceptions are made for patients who have been pregnant in the last 12 months and patients with IUDs or a LARC.
- Subject Inclusion:
- For Unaffected High Risk Premenopausal Women with BRCA mutations
- The participant is between 25 and 45 years of age.
- The participant is female.
- The patient has a known BRCA mutation.
- Have regular menstrual (21-35 days); 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. Exceptions are made for patients who have been pregnant in the last 12 months and patients with IUDs or a LARC.
- Subject Inclusion:
- For affected BRCA1 and BRCA2 mutation carriers, affected women with non-BRCA mutations, and BC patients with no mutations (control)
- 1 . Premenopausal women age 21-45 with stage 0-3 breast cancer. 2. No prior ovarian surgery or ovarian disease. 3. No prior chemotherapy. 4. Regular menstrual periods (21-35 days), no PCOS. 5. No hormonal contraception within the prior 4 weeks. 6. 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.
- 7. Receiving an anthracycline (typically doxorubicin/Adriamycin) and Cy (AC)-based chemotherapy protocol.
Who cannot join
- 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
Show all 18Show fewer
- Current pregnancy.
- Subject Exclusion Criteria:
- For Unaffected High Risk Premenopausal Women with BRCA mutation
- Participant has therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.
- Participant has ovarian resection, unilateral or bilateral oophorectomy, radiation to pelvic region.
- Participant has Plans for risk-reducing bilateral oophorectomy within one year of completion of chemotherapy.
- Participant has 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.
- Participant has a family history of a first-degree relative with non-surgical menopause < age 40.
- Participant is currently pregnant. For affected BRCA1 and BRCA2 mutation carriers, affected women with non-BRCA mutations, and BC patients with no mutations (control)
- 1. 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.
- 2. 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. 3. 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. 4. 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.
- 5. 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shari Goldfarb, MD contact
Minna Lee, MD contact
8 sites in 1 country
United States8 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Shari Goldfarb, MD, 646-888-5080
Minna Lee, MD, 646-888-6898
- Active, not recruiting
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Shari Goldfarb, MD, 646-888-5080
About this study
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
The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.
- Conditions
- Breast Cancer
- Being tested
- Blood draw and questionnaires
- Keywords
- Breast, Questionaires, Blood draw, BRCA1, BRCA2, 08-156
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw and questionnairesOther
Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center
↓ Baseline evaluation: Blood draw and baseline reproductive health questionnaire (Appendix A)/menstrual calendar (Appendix C) / sexual health questionnaires (Appendices E, F, G)
↓ Start planned therapy (or observation)
↓ Evaluation at completion of chemotherapy Blood draw and collection of monthly menstrual calendars
↓ One year post chemo Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B)
↓ Annual follow-up x 3 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) )/ sexual health questionnaires (Appendices E, F, G)
Blood draw and questionnairesOther
Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center
↓ Baseline evaluation: Blood draw and baseline reproductive and sexual health questionnaires (Appendices A, E, F, G)/menstrual calendar (Appendix C)
↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G)
↓ Annual follow-up years x 3 if feasible Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G)
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Women with Early Stage Breast Cancer | Not described Receives: Other: Blood draw and questionnaires | |
| Unaffected High Risk Women with BRCA mutations | Not described Receives: Other: Blood draw and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)
in premenopausal breast cancer patients \& to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women.
Measured: 2 years
To study sexual health and function in unaffected high risk BRCA mutation carriers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 609 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, New York Presbyterian Hospital, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Shari Goldfarb, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823654
- Sponsor's protocol ID
- 08-156
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2009
- Last updated
- 16 Oct 2026
- Results posted
- No
Publications
Oktay KH, Bedoschi G, Goldfarb SB, Taylan E, Titus S, Palomaki GE, Cigler T, Robson M, Dickler MN. Increased chemotherapy-induced ovarian reserve loss in women with germline BRCA mutations due to oocyte deoxyribonucleic acid double strand break repair deficiency. Fertil Steril. 2020 Jun;113(6):1251-1260.e1. doi: 10.1016/j.fertnstert.2020.01.033. Epub 2020 Apr 22.
PubMed 32331767
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00823654
- Acronym / sponsor ID
- 08-156
- Conditions
- Breast Cancer
- Keywords
- Breast, Questionaires, Blood draw, BRCA1, BRCA2, 08-156
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 609 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Yale University, New York Presbyterian Hospital, Weill Medical College of Cornell University
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women with Early Stage Breast Cancer | – | Other: Blood draw and questionnaires |
| Unaffected High Risk Women with BRCA mutations | – | Other: Blood draw and questionnaires |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (17 listed)
- For Premenopausal Women with Early Stage Breast Cancer
- Participant is between 18-44 years old.
- Participant is premenopausal.
- Participant is female.
- Participant has a known breast cancer diagnosis of 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw and questionnairesIdentify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive health questionnaire (Appendix A)/menstrual calendar (Appendix C) / sexual health questionnaires (Appendices E, F, G) ↓ Start planned therapy (or observation) ↓ Evaluation at completion of chemotherapy Blood draw and collection of monthly menstrual calendars ↓ One year post chemo Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) ↓ Annual follow-up x 3 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) )/ sexual health questionnaires (Appendices E, F, G) | Other | Premenopausal Women with Early Stage Breast Cancer |
| Blood draw and questionnairesIdentify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive and sexual health questionnaires (Appendices A, E, F, G)/menstrual calendar (Appendix C) ↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G) ↓ Annual follow-up years x 3 if feasible Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G) | Other | Unaffected High Risk Women with BRCA mutations |
Primary outcome
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.
5 secondary outcomes
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
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
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
To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women.
Time frame: 2 years
To study sexual health and function in unaffected high risk BRCA mutation carriers
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 32331767Oktay KH, Bedoschi G, Goldfarb SB, Taylan E, Titus S, Palomaki GE, Cigler T, Robson M, Dickler MN. Increased chemotherapy-induced ovarian reserve loss in women with germline BRCA mutations due to oocyte deoxyribonucleic acid double strand break repair deficiency. Fertil Steril. 2020 Jun;113(6):1251-1260.e1. doi: 10.1016/j.fertnstert.2020.01.033. Epub 2020 Apr 22.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari Goldfarb, MD contact
Minna Lee, MD contact
Shari Goldfarb, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shari Goldfarb, MD (646-888-5080), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.