Phase 2
Completed N=6
AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00076024 ↗Enrolled (actual)
6
Serious AEs
39.2%
Results posted
Mar 2012
Primary outcomePrimary: Time to Tumor Progression (TTP) — 247; 215 days — p=0.156
Summary
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Tumor Progression (TTP) |
247; 215 | 0.156 |
| SECONDARY Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind) |
41.1; 23.6 | 0.038 sig |
| SECONDARY Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label) |
6.3 | — |
| SECONDARY Duration of Response (DR) for Phase 2 (Double-blind) |
211; 149 | — |
| SECONDARY Duration of Response (DR) for Phase 2 (Open-label) |
1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
- Adequate bone marrow, liver, and renal function
Exclusion Criteria
- Adjuvant chemotherapy given in the past 12 months
- Uncontrolled brain metastases
Data sourced from ClinicalTrials.gov (NCT00076024). 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.