Status:
TERMINATED
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
15-46 years
Phase:
PHASE3
Brief Summary
Primary Objective: * To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primar...
Detailed Description
Goserelin is designed to block hormones that can regulate your menstruation by affecting the pituitary gland (part of brain). If you are found to be eligible to take part in this study, you will be r...
Eligibility Criteria
Inclusion
- Female patients older than 15 years and younger than 46 years.
- Primary breast cancer (Stage I, II, or III).
- Pathologically confirmed invasive breast carcinoma.
- Negative hormone-receptor status. (Negative defined as ER- and PR- staining in less than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein on ligand-binding or enzyme-linked immunoassay).
- Premenopausal, verified before chemotherapy is begun as satisfying both:
- Cyclic vaginal bleeding.
- Follicle-stimulating hormone (FSH) is less than or equal to 15 IU/L. If patients are taking oral contraceptives, FSH must be measured 1-2 weeks after discontinuation. If FSH is greater than 15 and the patient has regular menses, gynecologic consultation will be required for a decision on premenopausal status.
- Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
- Treatment with at least four (4) cycles of chemotherapy as planned.
- Zubrod performance score of 0 or 1.
- Must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
- Willingness to use barrier contraception if sexually active.
Exclusion
- Pregnancy. Women must have a negative serum pregnancy test before initiation of injection.
- Hypersensitivity to any GnRH analog.
- Previous receipt of systemic chemotherapy.
- To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.
- Stage IV breast cancer.
- Prothrombin time (PT) and partial prothrombin time (PTT) with INR \> 1.5
- Platelets \< 50,000/mm\^3
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00429403
Start Date
August 1 2006
End Date
July 1 2010
Last Update
May 9 2016
Active Locations (2)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
St. Luke's International Hospital
Tokyo, Japan