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A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

25 Years
50 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

estimates of serum concentrations

Outcome Description:

To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy. Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Norah L Henry, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2007.081



Start Date:

September 2007

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • premenopausal women with breast cancer
  • Breast Neoplasms



University of Michigan Cancer Center Ann Arbor, Michigan  48109