Premenopausal women who are diagnosed with breast cancer are frequently treated with
chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary
loss of menstrual periods to permanent menopause. It is difficult to predict how an
individual's ovarian function will be affected by chemotherapy. There are a number of
hormones which can be measured in the blood which are related to fertility and ovarian
function. The levels of these hormones may change with chemotherapy, and may relate to the
effect of chemotherapy on the ovaries.
In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed
with breast cancer and will be treated with chemotherapy. We will check blood levels of the
hormones before, immediately after, and 1 year after treatment with chemotherapy. We will
only be checking these blood tests for this study; the type of chemotherapy given will be up
to the patient and her oncologist. We will also ask some questions about factors that can
influence the levels of these hormones, such as number of children, age of menopause of
other family members, and smoking history. The results from this study will be used to help
us develop future studies looking at changes in ovarian function with chemotherapy, and the
effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
- Subjects must be women with a histologically confirmed invasive adenocarcinoma of the
breast (stage I, II, or III) with no evidence of metastatic disease.
- Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients
may receive concurrent trastuzumab as indicated. If a patient has not yet undergone
final surgical resection, it must be highly likely (but is not required to be
definite) that the patient will be treated with adjuvant chemotherapy.
- Patients must have:
- Reached their 25th birthday and not yet reached their 51st birthday at the time
of study enrollment, AND
- Had menses within 3 months prior to starting chemotherapy
- Patients must not have received prior cytotoxic chemotherapy for any oncologic,
rheumatologic, or dermatologic condition.
- Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must
not have had prior hysterectomy
- ECOG performance status 0 - 2
- Pregnant or nursing women may not participate. Women of reproductive potential must
agree to use an effective non-hormonal contraceptive method, such as condoms, tubal
ligation, non-hormonal intrauterine device, partner sterilization, and abstinence
- All patients must be informed of the investigational nature of this study and given
written informed consent in accordance with institutional and federal guidelines.