N/A
N=232
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Breast Cancer · Ovarian Insufficiency · Ovarian Failure
Bottom Line
View on ClinicalTrials.gov: NCT01197456 ↗Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis — 27; 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis |
27; 11 | — |
| SECONDARY Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea |
62; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01197456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.