A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | July 2009 |
| End Date: | October 2013 |
An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer
This open-label, multi-center study will assess the safety and tolerability of adding
trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanced or metastatic
HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each
3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to
trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles
for patients with locally advanced breast cancer, until disease progression or unacceptable
toxicity occurs for patients with metastatic breast cancer.
trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanced or metastatic
HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each
3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to
trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles
for patients with locally advanced breast cancer, until disease progression or unacceptable
toxicity occurs for patients with metastatic breast cancer.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- ECOG performance status 0-1 (ECOG performance status of 2 will be allowed if only due
to debilitating bone disease)
- HER2-positive metastatic or locally advanced breast cancer
- For MBC (metastatic breast cancer) patients:
- documented metastatic or inoperable locally advanced (without meeting LABC criteria)
disease, amenable for treatment with docetaxel
- history of disease progression within 3 months prior to study entry
- For LABC (locally advanced breast cancer) patients:
- newly diagnosed locally advanced breast cancer, Stage IIIA-IIIC (AJCC staging system)
Exclusion Criteria:
- Pregnant or lactating women
- Significant cardiac disease
- Inadequate bone marrow, liver or renal function
- For MBC patients:
- patients must not have received radiotherapy for the treatment of metastatic or
locally recurrent/advanced disease other than for the relief of pain in progressing
metastatic bone lesions and/or brain metastases
- brain metastases that are untreated, symptomatic or require therapy to control
symptoms
- For LABC patients:
- clinically or radiologically detectable metastasis (M1 disease)
- patients for whom surgery as primary intent procedure is the best option to treat
their disease
- previous systemic or loco regional anti-cancer therapy for locally advanced disease
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