Clinical trial NCT00555477: Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Official title: Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: premenopausal breast cancer with chemotherapy-induced ovarian failure
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2007-11-08
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Norah L. Henry, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry NL, Xia R, Banerjee M, Gersch C, McConnell D, Giacherio D, Schott AF, Pearlman M, Stearns V, Partridge AH, Hayes DF. Predictors of recovery of ovarian function during aromatase inhibitor therapy. Ann Oncol. 2013 Aug;24(8):2011-6. doi: 10.1093/annonc/mdt149. Epub 2013 Apr 23.