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Study stopped due to low accrual.
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Primary Objective:
Secondary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goserelin | Experimental | 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. |
|
| No Goserelin | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin | Drug | 3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year |
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Inclusion Criteria:
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:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naoto Ueno, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| St. Luke's International Hospital |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Study terminated early due to slow accrual.
Period of Recruitment: August 30, 2006 to August 25, 2009. All patient recruitment made at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Goserelin | 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. |
| FG001 | No Goserelin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Goserelin | 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. |
| BG001 | No Goserelin | |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was per protocol. Limited analysis due to low recruitment and early termination. | Posted | Number | participants | Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year |
|
2 years and 6 months
There were no participants in the No Goserelin group so the number of participants at risk or affected was null for both serious and/or other [non-serious] adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Goserelin | 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naoto Ueno, MD / Professor | UT MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Tokyo |
| Japan |
| Total |
Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Goserelin |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | No Goserelin | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |