Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

Phase 2 Completed 32 enrolled Celgene Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Timeline

Start: 2004-06-01
Primary completion: 2008-10-01
Completion: 2008-10-01

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The overall response rate (ORR) was 62.5% (95% CI, 45.7%-79.3%) PMID 20705560 ↗

Publications

Results Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	2 unknown	Intravenous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous