Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

Breast Cancer Clinical Trial

— POISE  

Official title:

Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197456
• Other study ID #: UCSD POISE
• Secondary ID: K23HD058799
• Status: Completed
• Start date: September 24, 2008
• Est. completion date: July 18, 2019

Study information

• Verified date: April 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: July 18, 2019
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Ovarian Failure
• Ovarian Insufficiency

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	American Cancer Society, Inc., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

Homer MV, Charo LM, Natarajan L, Haunschild C, Chung K, Mao JJ, DeMichele AM, Su HI. Genetic variants of age at menopause are not related to timing of ovarian failure in breast cancer survivors. Menopause. 2017 Jun;24(6):663-668. doi: 10.1097/GME.00000000 — View Citation

Su HC, Haunschild C, Chung K, Komrokian S, Boles S, Sammel MD, DeMichele A. Prechemotherapy antimullerian hormone, age, and body size predict timing of return of ovarian function in young breast cancer patients. Cancer. 2014 Dec 1;120(23):3691-8. doi: 10. — View Citation

Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimüllerian hormone levels among commercially available immunoassays. Fertil Steril. 2014 Jun;101(6):1766-72.e1. doi: 10.1016/j.fertnstert.2014.02.046. Epub 2014 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis	Number of participant without of menses for 12 months after breast cancer diagnosis	Years 1-5
Secondary	Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea	Number of participants who experience return of menses after 3 months of amenorrhea	Years 1-5