Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

King Faisal Specialist Hospital & Research Center0 sites416 target enrollmentNovember 2009

ConditionsBreast Cancer

InterventionsStandard cyclophosphamide Goserelin (Zoladex)

DrugsStandard cyclophosphamide Goserelin (Zoladex)

Overview

Phase: Phase 3
Intervention: Standard cyclophosphamide
Conditions: Breast Cancer
Sponsor: King Faisal Specialist Hospital & Research Center
Enrollment: 416
Primary Endpoint: The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

King Faisal Specialist Hospital & Research Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, or IIIA invasive breast cancer. Patients who have completed surgery must have pathologic Stage I, II, or IIIa disease. Patients to be treated in the preoperative setting may be staged clinically but must have operable disease. For the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and estradiol levels in the premenopausal range.
•Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative.
•Patients must be of age 18 or greater and under age
•The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
•For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting
•Patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.
•Patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition. Patients currently enrolled on S0221 are eligible for this study.
•Patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: Women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. In addition, for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization.
•Women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation of FSH and estradiol levels in the premenopausal range.
•No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been diseasefree for five years after treatment with curative intent.