Phase 2
Completed N=50
A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00490646 ↗Enrolled (actual)
50
Serious AEs
39.6%
Results posted
Jul 2012
Primary outcomePrimary: Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1) — 60.0; 52.0 percentage of participants
Summary
The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1) |
60.0; 52.0 | — |
| PRIMARY Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
3; 2; 12; 11; 6; 9 | — |
| SECONDARY Progression Free Survival (PFS) |
11.3; 13.0 | — |
| SECONDARY Time to Response |
10.1; 7.3 | — |
| SECONDARY Duration of Response |
11.5; 16.5 | — |
| 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 |
1; 1; 1; 0; 6; 13 | — |
| SECONDARY Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0 |
6; 1; 7; 1; 8; 15 | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0 |
11; 8; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
- Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
- Measurable disease
- Left Ventricular Ejection Fraction (LVEF) ≥50%
Exclusion Criteria
- Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
- Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
- Neuropathy > Grade 1
- Significant cardiovascular disease
- Any brain metastases
Data sourced from ClinicalTrials.gov (NCT00490646). 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.