Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer

Stopped early · Phase 3

Conditions studied: Breast Cancer

In brief

Primary Objective: * To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses. Secondary Objectives: * To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy. * To determine the overall survival and disease-free survival times of study participants.

Key facts

Study ID

NCT00429403

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2006-08-01

Expected to finish

2010-07-01

Last updated by the study team

2016-05-09

Who can join

Age: 15 and older, up to 46. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States
• St. Luke's International Hospital — Tokyo, Japan

Full record on ClinicalTrials.gov

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