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

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

May 31, 2011

Conditions
Triple Negative Locally Advanced Non-resectable Breast CancerMetastatic Breast Cancer
Interventions
DRUG

ixabepilone

"injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.~Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria."

DRUG

ixabepilone + cetuximab

"Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.~Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.~Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.~Cetuximab 400 mg/m\^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m\^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria."

Trial Locations (19)

1090

Local Institution, Vienna

8036

Local Institution, Graz

21079

Local Institution, Dijon

22015

Local Institution, Saint-Brieuc

31052

Local Institution, Toulouse

44805

Local Institution, Saint-Herblain

54642

Local Institution, Thessaloniki

64100

Local Institution, Bayonne

69008

Local Institution, Lyon

75651

Local Institution, Paris

80131

Local Institution, Napoli

80952

Local Institution, Gdansk

656 53

Local Institution, Brno

128 08

Local Institution, Prague

150 06

Local Institution, Prague

10-513

Local Institution, Olsztyn

08036

Local Institution, Barcelona

08208

Local Institution, Barcelona

08221

Local Institution, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

R-Pharm

INDUSTRY