Clinical trial NCT00644683: A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
Official title: A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: premenopausal women with breast cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2008-03-27
Enrollment: 28
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 during chemotherapy.
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Primary outcomes:
measure: estimates of serum concentrations
timeFrame: 1 year
Secondary outcomes:
measure: serum concentrations of reproductive hormones
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry NL, Xia R, Schott AF, McConnell D, Banerjee M, Hayes DF. Prediction of postchemotherapy ovarian function using markers of ovarian reserve. Oncologist. 2014 Jan;19(1):68-74. doi: 10.1634/theoncologist.2013-0145. Epub 2013 Dec 6.