Clinical trial NCT00633464: Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
Official title: Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative (ER, PR, Her2 Negative) Locally Advanced Non-resectable and/or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 79
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 study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], Human Epidermal Growth Factor Receptor 2 \[HER2\] negative) locally advanced non-resectable and/or metastatic breast cancer


Eligibility criteria: Inclusion Criteria:

* Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
* Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

Exclusion Criteria:

* Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
* Neuropathy \> Grade 1
* Prior systemic therapy for metastatic disease

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])
timeFrame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)
measure: Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST)
timeFrame: Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months).
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months)
measure: Time to Response
timeFrame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.)
measure: Duration of Response
timeFrame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 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. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm)
measure: Number of Participants With Hematology Abnormalities
timeFrame: Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)
measure: Number of Participants With Serum Chemistry Abnormalities
timeFrame: Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brno
country: Czech Republic
facility: Local Institution
city: Prague 5
country: Czech Republic
facility: Local Institution
city: Praha 2
country: Czech Republic
facility: Local Institution
city: Bayonne
country: France
facility: Local Institution
city: Dijon Cedex
country: France
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Saint Brieuc
country: France
facility: Local Institution
city: Saint Herblain Cedex
country: France
facility: Local Institution
city: Toulouse Cedex
country: France
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: