609 Participants Needed

Therapy Effects on Ovarian Reserve for Breast Cancer

Recruiting at 9 trial locations
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ML
Shari Goldfarb, MD profile photo
Overseen ByShari Goldfarb, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Anthracyclines, Tamoxifen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how BRCA mutations affect the ovaries, potentially influencing a woman's ability to conceive or causing early menopause. Researchers will monitor hormone levels in participants' blood before, during, and after breast cancer treatment using simple blood tests and questionnaires about menstrual cycles and health. This study is ideal for premenopausal women with early-stage breast cancer or those with a BRCA mutation who experience regular menstrual cycles and have no history of infertility.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance understanding of BRCA mutations and reproductive health.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that you should not have used hormonal contraception in the prior 4 weeks if you are in the affected BRCA1 and BRCA2 mutation carriers group.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to understand how therapies for early-stage breast cancer or BRCA mutations affect ovarian reserve in premenopausal women. Unlike typical treatment studies that focus on drugs or surgical interventions, this trial uses blood draws and questionnaires to gather data on serum biomarkers. These biomarkers could offer new insights into how cancer treatments impact fertility, an area that is often overlooked. By focusing on ovarian reserve, this trial hopes to provide valuable information that could lead to better fertility-preserving strategies for women undergoing cancer treatment.

Who Is on the Research Team?

SG

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

For Premenopausal Women with Early Stage Breast Cancer
ECOG performance status 0-1
Premenopausal Women ages 25-45 with known BRCA mutations
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cancer treatment and have blood levels of hormones checked before, during, and after treatment

1 year

Follow-up

Participants are monitored for changes in serum AMH and other hormone levels, and complete questionnaires about menstrual cycles and health

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Blood draw and questionnaires
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Unaffected High Risk Women with BRCA mutationsExperimental Treatment1 Intervention
Group II: Premenopausal Women with Early Stage Breast CancerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

New York Presbyterian Hospital

Collaborator

Trials
77
Recruited
57,300+
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