Overview

This trial is active, not recruiting.

Conditions breast cancer, ovarian insufficiency, ovarian failure
Sponsor University of California, San Diego
Collaborator University of Pennsylvania
Start date September 2008
End date June 2016
Trial size 200 participants
Trial identifier NCT01197456, K23HD058799, UCSD POISE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Breast cancer patients who will undergo chemotherapy
Breast cancer patients who will not undergo chemotherapy

Primary Outcomes

Measure
Ovarian insufficiency
time frame: Years 1-5

Secondary Outcomes

Measure
Return of menses
time frame: Years 1-5

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Diego.