Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

Completed

• Conditions: Breast Cancer; Ovarian Failure; Ovarian Insufficiency

• Registration Number: NCT01197456
• Lead Sponsor: University of California, San Diego

Brief Summary

More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.

The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-24
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2016-06-30
• Study Completion: 2019-07-18
• Results First Submitted: 2019-07-18
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 232

Inclusion Criteria

• New diagnosis of breast cancer (Stages 0-III)
• Age <=45
• Premenopausal (at least one menses over past year)
• Has a uterus and at least one ovary

Exclusion Criteria

• Prior chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis	Years 1-5	Number of participant without of menses for 12 months after breast cancer diagnosis

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea	Years 1-5	Number of participants who experience return of menses after 3 months of amenorrhea

Trial Locations

Locations (2)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States