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


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

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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:

Interventional

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:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2007.044

NCT ID:

NCT00555477

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

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Dana-Farber Cancer CenterBoston, Massachusetts  02115
Sidney Kimmel Comprehensive Center at Johns HopkinsBaltimore, Maryland  21231-2410