Breast Cancer, Ovarian Failure, Ovarian Insufficiency
Conditions
Keywords
Breast cancer, Ovarian insufficiency, Ovarian failure, Reproduction
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.
Interventions
None listed
Sponsors
University of Pennsylvania
University of Southern California
American Cancer Society, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis | Years 1-5 | Number of participant without of menses for 12 months after breast cancer diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea | Years 1-5 | Number of participants who experience return of menses after 3 months of amenorrhea |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exposed/Chemotherapy Breast cancer patients who will undergo chemotherapy | 171 |
| Unexposed Breast cancer patients who will not undergo chemotherapy | 61 |
| Total | 232 |
Baseline characteristics
| Characteristic | Unexposed | Exposed/Chemotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 171 Participants | 232 Participants |
| Age, Continuous | 41.0 years STANDARD_DEVIATION 5.7 | 38.7 years STANDARD_DEVIATION 5.1 | 39.3 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 61 Participants | 171 Participants | 232 Participants |
| Sex: Female, Male Female | 61 Participants | 171 Participants | 232 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 171 | 1 / 61 |
| other Total, other adverse events | 0 / 171 | 0 / 61 |
| serious Total, serious adverse events | 0 / 171 | 0 / 61 |
Outcome results
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
Time frame: Years 1-5
Population: 25 participants could not be evaluated for this outcome due to censoring for cancer recurrence, death, bilateral salpingo-oophorectomy, or hysterectomy.~38 additional participants could not be evaluated for this outcome due to loss to follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exposed/Chemotherapy | Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis | 27 Participants |
| Unexposed | Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis | 11 Participants |
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
Time frame: Years 1-5
Population: We did not undertake this analysis for participants who did not undergo chemotherapy (unexposed) or were censored for recurrence, death, hysterectomy or bilateral salpingo-oophorectomy (n=108) as this measure is not applicable
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposed/Chemotherapy | Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea | 62 Participants |
| Unexposed | Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea | 0 Participants |