CIRG
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BCIRG 101-102
Study: BCIRG 101 and 102
| Title | Open label Multicentre phase II pilot studies with Herceptin in combination with docetaxel and platinum salts (Cis or Carboplatin) (TCH) as therapy for advanced breast cancer in women with tumors over-expressing the HER2-neu proto-oncogene | ||||
| Study Chairs | BCIRG 101: Jean-Marc Nabholtz, MD, Dennis Slamon, MD BCIRG 102: Dennis Slamon, MD, for the UCLA Community Research Network | ||||
| Sponsor | Aventis Oncology | ||||
| Rationale | Based on preclinical data, the synergistic effect is greatest with Herceptin and the chemotherapies Taxotere, and platinum salts. These pilot phase II studies were conducted to determine the feasibility in metastatic breast cancer patients of the TCH combination. The results indicate that both platinum salts are feasible and the combination is quite active. These studies provided the necessary information to launch the phase III pivotal trials BCIRG 006 and BCIRG 007. | ||||
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Study Publication
ECCO-11
Abstract
ECCO-11
Poster
ECCO11 ppt slides |
“Results of 2 open-Label, Multicenter phase II studies of docetaxel, platinum salts and trastuzumab in HER2-positive Advanced BC” J Natl Cancer Inst, 19 May 2004 - 96 n° 10 p 759-69 by Dr.M.Pegram Click here to view a PDF version of Abstract #695, Nabholtz et al.
Click here to view poster in PDF Click here to download the powerpoint slides of the final results as presented at ECCO-11 in October 2001 | ||||
| Number of Patients | 62 patients on each study. | ||||
| Status | Enrollment complete. | ||||
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