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Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)

Outcome Description:

Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.

Outcome Time Frame:

Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Italy: Ministry of Health

Study ID:

CA163-140

NCT ID:

NCT00490646

Start Date:

February 2008

Completion Date:

November 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Locally advanced and/or metastatic breast cancer
  • Breast Neoplasms

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