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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | Genentech |
| ClinicalTrials.gov Identifier: | NCT00781612 |
Purpose
This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment on this protocol.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: trastuzumab-MCC-DM1 Drug: pertuzumab Drug: paclitaxel Drug: trastuzumab Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Treated With the Equivalent T-DM1 Regimen in a Genentech and/or F. Hoffmann-La Roche Ltd.-Sponsored T-DM1 Study |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: trastuzumab-MCC-DM1
Intravenous repeating dose
Drug: pertuzumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: trastuzumab
Intravenous repeating dose
Drug: docetaxel
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00781612 History of Changes |
| Other Study ID Numbers: | TDM4529g, BO25430 |
| Study First Received: | October 27, 2008 |
| Last Updated: | December 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Trastuzumab |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |