Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Genentech |
---|---|
Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00781612 |
This is a multicenter, open-label extension study. Patients receiving T-DM1 in a Genentech-sponsored study who completed the parent study or who continue to receive T-DM1 at the time of the parent study closure are eligible for continued treatment on this protocol. The dose and schedule of T-DM1 administered will be that given in the parent study. Patients can receive T-DM1 until disease progression or unacceptable toxicity for as long as the extension study remains open. Patients randomized to non-T-DM1-containing treatment arms of T-DM1 trials are not eligible for this study.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: trastuzumab-MCC-DM1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) in Patients Previously Treated With T-DM1 in a Genentech Sponsored T-DM1 Study |
Estimated Enrollment: | 50 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: trastuzumab-MCC-DM1
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | TDM4529g |
Study First Received: | October 27, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00781612 |
Health Authority: | United States: Food and Drug Administration |
TDM1 Trastuzumab MBC HER2 HER2-positive breast cancer |
Myotonia atrophica Skin Diseases Myotonic Dystrophy Trastuzumab |
Breast Neoplasms Dystrophia myotonica 1 Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |