Phase 2
Completed N=150
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00191451 ↗Enrolled (actual)
150
Serious AEs
21.4%
Results posted
Nov 2009
Primary outcomePrimary: Overall Tumor Response — 6; 0; 1; 26 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Tumor Response |
6; 0; 1; 26; 13; 15 | — |
| SECONDARY Duration of Response |
6.9; 6.4; 5.6 | — |
| SECONDARY Number of Patients Who Experienced Alopecia |
21; 17; 16 | — |
| SECONDARY Time to Disease Progression (TTP) |
7.2; 5.6; 4.6 | — |
| SECONDARY Percentage of Patients With Overall Survival at 1 Year and 2 Years |
90.0; 67.5; 47.8; 73.3; 41.4; 20.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00191451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.