Phase 2
N=79
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
Triple Negative Locally Advanced Non-resectable Breast Cancer · Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00633464 ↗Enrolled (actual)
79
Serious AEs
27.3%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST]) — 30.0; 35.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ixabepilone (Drug); ixabepilone + cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- R-Pharm
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST]) |
30.0; 35.9 | — |
| PRIMARY Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST) |
3; 0; 9; 14; 17; 12 | — |
| SECONDARY Progression Free Survival (PFS) |
4.1; 4.1 | — |
| SECONDARY Time to Response |
8.8; 6.5 | — |
| SECONDARY Duration of Response |
4.5; 4.5 | — |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 |
8; 9; 8; 7; 0; 2 | — |
| SECONDARY Number of Participants With Hematology Abnormalities |
33; 34; 13; 16; 33; 31 | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities |
9; 17; 0; 1; 10; 18 | — |
Summary
The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer
Eligibility Criteria
Inclusion Criteria
- Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
- Prior adjuvant or neoadjuvant anthracycline-based chemotherapy
Exclusion Criteria
- Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
- Neuropathy > Grade 1
- Prior systemic therapy for metastatic disease
Data sourced from ClinicalTrials.gov (NCT00633464). 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.