Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
15 Years
46 Years
Female
Breast Cancer
Trial Information
Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
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 randomly assigned
(as in the toss of a coin) to one of two treatment groups. You will either be assigned to
receive goserelin or no treatment. There is an equal chance of being assigned to either
group.
If you are assigned to receive goserelin, the first dose will be given as an injection under
the skin, 1 week before you start chemotherapy. You will then receive chemotherapy as part
of your standard of care. Following the first dose of goserelin, you will be given a
goserelin injection into the skin, once a month until 3 weeks after the last chemotherapy
dose.
You will be taken off study if intolerable side effects occur during this study. After you
are finished with chemotherapy, you will have a series of follow-up visits. During the
period of follow-up, you will have a medical history, physical exam, and blood tests (2-3
teaspoons) to evaluate your ovarian function, every 3 months for 1 year and then at 24
months. You will be asked to fill out questionnaires about your menstrual history at these
visits. The questionnaires should take about 15 minutes to complete. You will be also
asked to fill out questionnaires about your quality of life at 12 and 24 months. The
questionnaires should take about 30 minutes to complete.
This is an investigational study. Goserelin is commercially available and has been approved
by the FDA for use in breast cancer patients. Its use in this study is investigational.
About 148 patients will take part in this multicenter study. Up to 36 patients will be
enrolled at M.D. Anderson.
Inclusion Criteria:
1. Female patients older than 15 years and younger than 46 years.
2. Primary breast cancer (Stage I, II, or III).
3. Pathologically confirmed invasive breast carcinoma.
4. 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).
5. 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.
6. Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
7. Treatment with at least four (4) cycles of chemotherapy as planned.
8. Zubrod performance score of 0 or 1.
9. Must consent to preservation of their ovarian function and indicate their awareness
of the investigational nature of this study, in keeping with institutional policy.
10. Willingness to use barrier contraception if sexually active.
Exclusion Criteria:
1. Pregnancy. Women must have a negative serum pregnancy test before initiation of
injection.
2. Hypersensitivity to any GnRH analog.
3. Previous receipt of systemic chemotherapy.
4. To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.
5. Stage IV breast cancer.
6. Prothrombin time (PT) and partial prothrombin time (PTT) with INR > 1.5
7. Platelets < 50,000/mm^3
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients With Response (FSH Level + Vaginal Bleeding)
Outcome Description:
Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.
Outcome Time Frame:
Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Safety Issue:
No
Principal Investigator
Naoto Ueno, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0464
NCT ID:
NCT00429403
Start Date:
August 2006
Completion Date:
July 2010
Related Keywords:
- Breast Cancer
- Breast Cancer
- Chemotherapy
- Ovarian Function
- Goserelin
- Zoladex
- Ovary function
- Fertility
- Early Menopause
- Breast Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
