Know Cancer

forgot password

Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Phase 2
18 Years
60 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Inclusion Criteria:

To be eligible for this study:

1. You must be at least 18 years of age and not older than 60 years of age

2. You have breast cancer which was confined to the breast and lymph nodes under the
arm, and have no evidence of cancer elsewhere

3. You must have had surgical removal of your tumor, and if indicated, radiation therapy
must have been completed or planned

4. Your tumor must express estrogen and/or progesterone receptors

5. You must have had a menstrual period within 6 months before starting chemotherapy for
your breast cancer.

6. You must have been treated with a chemotherapy regimen that includes cyclophosphamide
(Cytoxan). Your menstrual periods must have stopped for at least 8 weeks starting
during or after chemotherapy.

Exclusion Criteria:

You are not eligible to participate in this study if:

1. Your ovaries have been surgically removed, treated with radiation therapy, or if you
are taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the proportion of women in the 2 age groups who develop recovery of ovarian function within 12 months of Al Monotherapy

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Norah L. Henry, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Food and Drug Administration

Study ID:

UMCC 2007.044



Start Date:

August 2007

Completion Date:

January 2016

Related Keywords:

  • Breast Cancer
  • premenopausal breast cancer with chemotherapy-induced ovarian failure
  • Breast Neoplasms
  • Menopause, Premature
  • Primary Ovarian Insufficiency



University of Michigan Ann Arbor, Michigan  48109-0624
Dana-Farber Cancer Center Boston, Massachusetts  02115
Sidney Kimmel Comprehensive Center at Johns Hopkins Baltimore, Maryland  21231-2410