Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

April 30, 2010

Study Completion Date

November 30, 2012

Conditions
Breast Cancer
Interventions
DRUG

docetaxel

Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.

DRUG

erlotinib hydrochloride

OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.

Trial Locations (1)

44106-5065

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Paula Silverman, MD

OTHER

NCT00054275 - Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer | Biotech Hunter | Biotech Hunter