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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 November 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: November 19, 2014
Last verified: November 2014

January 14, 2009
November 19, 2014
January 2009
January 2016   (final data collection date for 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: 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.
To characterize the changes in serum AMH from baseline to one year post-chemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer and lymphoma patients. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823654 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 and lymphoma patients. [ 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 and lymphoma patients. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • To describe the impact of commonly used therapies for early-stage breast cancer and lymphoma on self-reported monthly menstrual cycles and future pregnancy/reproductive health. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood

Non-Probability Sample

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.

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

  • 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

  • Premenopausal Women with Early Stage Breast Cancer
    Intervention: Other: Blood draw and questionnaires
  • Unaffected High Risk Women with BRCA mutations
    Intervention: Other: Blood draw and questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
Yes
Contact: Maura Dickler, MD 646-888-4560
Contact: Kimberly Van Zee, MD 646-888-5362
United States
 
NCT00823654
08-156
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • New York Medical College
  • New York Presbyterian Hospital
  • Weill Medical College of Cornell University
Principal Investigator: Maura Dickler, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP