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

NCT ID: NCT00490646

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-11-30

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m\^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Ixabepilone 40 mg/m^2 was administered as a 3-hour I.V. continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity.

For the first cycle, ixabepilone was administered the day following the first dose of trastuzumab (in the first cycle trastuzumab was given on Day 0); in all the following cycles, ixabepilone was administered immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.

trastuzumab

Intervention Type: DRUG

Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.

Arm B

trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m\^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

docetaxel

Intervention Type: DRUG

Docetaxel 100 mg/m\^2 was administered as a 1-hour IV continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity. For the first cycle, docetaxel was administered the day following the first dose of trastuzumab (i.e. in the first cycle trastuzumab was given on Day 0); in all following cycles, docetaxel was administered immediately after trastuzumab if the preceding dose of trastuzumab was well tolerated.

trastuzumab

Intervention Type: DRUG

Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.

Interventions

ixabepilone

Ixabepilone 40 mg/m^2 was administered as a 3-hour I.V. continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity.

For the first cycle, ixabepilone was administered the day following the first dose of trastuzumab (in the first cycle trastuzumab was given on Day 0); in all the following cycles, ixabepilone was administered immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.

Intervention Type: DRUG

docetaxel

Docetaxel 100 mg/m\^2 was administered as a 1-hour IV continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity. For the first cycle, docetaxel was administered the day following the first dose of trastuzumab (i.e. in the first cycle trastuzumab was given on Day 0); in all following cycles, docetaxel was administered immediately after trastuzumab if the preceding dose of trastuzumab was well tolerated.

Intervention Type: DRUG

trastuzumab

Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.

Intervention Type: DRUG

Other Intervention Names

BMS-247550; Epothilone; IXEMPRA®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

R-Pharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Caen, , France

Local Institution

Grenoble, , France

Local Institution

Saint-Priest-en-Jarez, , France

Local Institution

Toulouse, , France

Local Institution

Athens, , Greece

Local Institution

Athens, , Greece

Local Institution

Pireaus, , Greece

Local Institution

Bologna, , Italy

Local Institution

Brescia, , Italy

Local Institution

Modena, , Italy

Local Institution

Napoli, , Italy

Local Institution

Roma, , Italy

Local Institution

Sora, , Italy

Local Institution

Madrid, , Spain

Local Institution

Madrid, , Spain

Local Institution

Ankara, , Turkey (Türkiye)

Local Institution

Ankara, , Turkey (Türkiye)

Local Institution

Izmir, , Turkey (Türkiye)

Local Institution

Izmir, , Turkey (Türkiye)

Countries

France; Greece; Italy; Spain; Turkey (Türkiye)

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Eudract No: 2007-000721-21

Identifier Type: -

Identifier Source: secondary_id

CA163-140

Identifier Type: -

Identifier Source: org_study_id