Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

NCT01197456 | Completed Results

• 2 other identifiers: UCSD POISEK23HD058799
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Ovarian Insufficiency; Ovarian Failure

Keywords

Breast cancer; Ovarian insufficiency; Ovarian failure; Reproduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea

  Years 1-5

Study Arms (2)

Exposed/chemotherapy

Breast cancer patients who will undergo chemotherapy

Unexposed

Breast cancer patients who will not undergo chemotherapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients

You may qualify if:

• 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

You may not qualify if:

• Prior chemotherapy

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Pennsylvania: collaborator
• University of Southern California: collaborator
• American Cancer Society, Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 25081546 RESULT

• 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.

  PMID: 28118297 RESULT

• 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.

  PMID: 24726216 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum DNA

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Irene Su, MD MSCE
• Organization: UC San Diego

hisu@ucsd.edu

858-822-5986

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: September 24, 2008
• Primary Completion: June 30, 2016
• Study Completion: July 18, 2019
• Last Updated: April 22, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Locations

US (2)