Back to resultsGoserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Goserelin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Chemotherapy, Ovarian Function, Goserelin, Zoladex, Ovary function, Fertility, Early Menopause
Eligibility Criteria
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:
- 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 Criteria:
- 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
Sites / Locations
- UT MD Anderson Cancer Center
- St. Luke's International Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Goserelin
No Goserelin
Arm Description
3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00429403
First Posted
January 29, 2007
Last Updated
April 5, 2016
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00429403
Brief Title
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
Official Title
Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to low accrual.
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Chemotherapy, Ovarian Function, Goserelin, Zoladex, Ovary function, Fertility, Early Menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goserelin
Arm Type
Experimental
Arm Description
3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
Arm Title
No Goserelin
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
Zoladex
Intervention Description
3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
Primary Outcome Measure Information:
Title
Number of Patients With Response (FSH Level + Vaginal Bleeding)
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.
Time Frame
Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoto Ueno, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's International Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
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Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
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