Breast Cancer
Conditions
Keywords
Breast Cancer, Chemotherapy, Ovarian Function, Goserelin, Zoladex, Ovary function, Fertility, Early Menopause
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 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.
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 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.
Interventions
DRUGGoserelin
3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 46 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Response (FSH Level + Vaginal Bleeding) | Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year | 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. |
Countries
Japan, United States
Participant flow
Recruitment details
Period of Recruitment: August 30, 2006 to August 25, 2009. All patient recruitment made at UT MD Anderson Cancer Center.
Pre-assignment details
Study terminated early due to slow accrual.
Participants by arm
| Arm | Count |
|---|---|
| Goserelin 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. | 1 |
| No Goserelin | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Goserelin | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 years | 0 years |
| Age, Categorical >=65 years | 0 years | 0 years |
| Age, Categorical Between 18 and 65 years | 1 years | 1 years |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Number of Patients With Response (FSH Level + Vaginal Bleeding)
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.
Time frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Population: Analysis was per protocol. Limited analysis due to low recruitment and early termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Goserelin | Number of Patients With Response (FSH Level + Vaginal Bleeding) | 1 participants |