A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00191451
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Diagnosis of metastatic breast cancer
- Able to visit the doctor's office at least every 14 days during the actual treatment
- Able to care for yourself, even if you cannot work or participate in other normal activities
- Your blood results must be adequate for therapy.
- If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.
- Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
- Be pregnant or breastfeeding
- Have cancer to the brain and has not been treated
- Have another active cancer besides breast cancer
- Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HER2+ Herceptin Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. HER2- (Taxane-) Gemcitabine Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). HER2+ Gemcitabine Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. HER2+ Carboplatin Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. HER2- (Taxane-) Carboplatin Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). HER2- (Taxane+) Carboplatin Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients). HER2- (Taxane+) Gemcitabine Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).
- Primary Outcome Measures
Name Time Method Overall Tumor Response baseline to disease progression/recurrence (up to 3.5 years) Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
- Secondary Outcome Measures
Name Time Method Duration of Response date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years) Among tumor responders, the duration of tumor response is measured from the date of response (complete response \[CR\] or partial response \[PR\]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.
Number of Patients Who Experienced Alopecia Baseline to 3.5 years Time to Disease Progression (TTP) randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years) If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.
Percentage of Patients With Overall Survival at 1 Year and 2 Years 1 Year, 2 Years Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Indianapolis, Indiana, United States