Clinical trial NCT01197456: Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Official title: Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ovarian Insufficiency
Ovarian Failure
Keywords: Breast cancer
Ovarian insufficiency
Ovarian failure
Reproduction
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Southern California
name: American Cancer Society, Inc.
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-09-09
Enrollment: 232
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed breast cancer patients

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.


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

Primary outcomes:
measure: Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis
timeFrame: Years 1-5
Secondary outcomes:
measure: Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea
timeFrame: Years 1-5
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
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: 10.1002/cncr.28942. Epub 2014 Jul 31.
citation: 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.
citation: 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.