Status:
COMPLETED
A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (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 participants:
- 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 participants:
- Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer \[AJCC\] staging system)
Exclusion
- Significant cardiac disease
- Inadequate bone marrow, liver or renal function
- For MBC participants:
- Participants 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; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.
- For LABC participants:
- Clinically or radiologically detectable metastasis (M1 disease)
- Participants for whom surgery as primary intent procedure is the best option to treat their disease
- Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00934856
Start Date
July 1 2009
End Date
October 1 2013
Last Update
April 6 2017
Active Locations (8)
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1
Charlotte, North Carolina, United States, 28203
2
Houston, Texas, United States, 77005
3
Dijon, France, 21079
4
Saint-Herblain, France, 44805