Predictors of Ovarian Insufficiency in Young Breast Cancer Patients (POISE)

• ClinicalTrials.gov Identifier: NCT01197456
• Recruitment Status: Completed
• First Posted: September 9, 2010
• Results First Posted: April 22, 2020
• Last Update Posted: April 22, 2020
• Sponsor: University of California, San Diego
• Collaborators: University of Pennsylvania; University of Southern California; American Cancer Society, Inc.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Hui-Chun Irene Su, University of California, San Diego

Study Description

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.

Condition or disease
Breast Cancer; Ovarian Insufficiency; Ovarian Failure

Study Design

• Study Type: Observational
• Actual Enrollment: 232 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
• Actual Study Start Date: September 24, 2008
• Actual Primary Completion Date: June 30, 2016
• Actual Study Completion Date: July 18, 2019

Groups and Cohorts

Group/Cohort
Exposed/chemotherapy; Breast cancer patients who will undergo chemotherapy
Unexposed; Breast cancer patients who will not undergo chemotherapy

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea [ Time Frame: Years 1-5 ]
   Number of participants who experience return of menses after 3 months of amenorrhea

Biospecimen Retention:   Samples With DNA

Serum DNA

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients

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

Contacts and Locations

Locations

United States, California

University of California, San Diego

La Jolla, California, United States, 92093

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of California, San Diego

University of Pennsylvania

University of Southern California

American Cancer Society, Inc.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Publications of Results:

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: 10.1002/cncr.28942. Epub 2014 Jul 31.

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.0000000000000817.

Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimullerian 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.

• Responsible Party: Hui-Chun Irene Su, Professor of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01197456
• Other Study ID Numbers: UCSD POISE; K23HD058799 ( U.S. NIH Grant/Contract )
• First Posted: September 9, 2010
• Results First Posted: April 22, 2020
• Last Update Posted: April 22, 2020
• Last Verified: April 2020

Keywords provided by Hui-Chun Irene Su, University of California, San Diego:

Breast cancer; Ovarian insufficiency; Ovarian failure; Reproduction

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases