A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00490646
• Date of registration: 21/06/2007
• Prospective Registration: Yes
• Primary sponsor: R-Pharm
• Public title: A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer
• Scientific title: Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer
• Date of first enrolment: February 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00490646
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France, Greece, Italy, Spain, Turkey

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: trastuzumab

Drug: ixabepilone

Drug: docetaxel

Primary Outcome(s)

Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [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).]

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

Secondary Outcome(s)

Duration of Response [Time Frame: From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)]

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 [Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)]

Progression Free Survival (PFS) [Time Frame: From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).]

Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0 [Time Frame: Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)]

Time to Response [Time Frame: From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)]

Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0 [Time Frame: Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)]

Secondary ID(s)

CA163-140

Eudract No: 2007-000721-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/07/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00490646