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

This study has been terminated.
(The study was stopped after 69 subjects were enrolled because of poor accrual.)
Sponsor:
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00555477
First received: November 6, 2007
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors.

In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study.

The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.


Enrollment: 69
Study Start Date: August 2007
Study Completion Date: September 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anastrozole Drug: anastrozole
1 mg tablet by mouth once a day
Other Name: Arimidex

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555477

Locations
United States, Maryland
Sidney Kimmel Comprehensive Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Norah L. Henry, M.D., Ph.D. University of Michigan
  More Information

Publications:
Responsible Party: Lynn Henry, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00555477     History of Changes
Other Study ID Numbers: UMCC 2007.044, HUM 12443
Study First Received: November 6, 2007
Results First Received: April 16, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan Cancer Center:
premenopausal breast cancer with chemotherapy-induced ovarian failure

Additional relevant MeSH terms:
Breast Neoplasms
Menopause, Premature
Primary Ovarian Insufficiency
Adnexal Diseases
Breast Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014