Phase 2
Completed N=147
Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line
Source: ClinicalTrials.gov NCT00191854 ↗Enrolled (actual)
147
Serious AEs
5.5%
Results posted
Aug 2009
Primary outcomePrimary: Best Overall Response — 1; 0; 1; 12 participants
Summary
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response |
1; 0; 1; 12; 8; 7 | — |
| SECONDARY Number of Participants With a Time to Treatment Failure (TTTF) Event |
15; 21; 21 | — |
| SECONDARY Progression Free Survival (PFS) |
4.8; 4.3; 4.8 | — |
| SECONDARY Duration of Response |
5.8; 3.2; 5.1 | — |
| SECONDARY Overall Survival |
15.5; 22.8; 20.1 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients with histological or cytological proven diagnosis of breast cancer
- Stage IV disease
- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
- Adequate organ function
Exclusion Criteria
- Prior chemotherapy for metastatic disease
- Previous radiation therapy is allowed but must not have included whole pelvis radiation
- Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
- Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia
Data sourced from ClinicalTrials.gov (NCT00191854). 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.