Predictors of Ovarian Insufficiency in Young Breast Cancer Patients



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:10/17/2018
Start Date:September 2008
End Date:June 2020

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

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.


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
We found this trial at
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sites
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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