Clinical trial NCT00490646: A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Locally advanced and/or metastatic breast cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)
timeFrame: 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)
measure: Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: 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 outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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).
measure: Time to Response
timeFrame: 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.)
measure: Duration of Response
timeFrame: 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.)
measure: 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
timeFrame: 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.)
measure: Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0
timeFrame: 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.)
measure: Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0
timeFrame: 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.)
Other outcomes:
Locations:
city: Caen
country: France
facility: Local Institution
city: Grenoble
country: France
facility: Local Institution
city: St Priest En Jarez
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Pireaus
country: Greece
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Sora
country: Italy
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: