A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Condition(s) studied
Investigational drug(s) / intervention(s)
Docetaxel: Docetaxel will be administered as per local prescribing information.
Paclitaxel: Paclitaxel will be administered as per local prescribing information.
Pertuzumab: Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
Trastuzumab: Trastuzumab will be administered as per local prescribing information.
Trastuzumab Emtansine: Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
Atezolizumab: Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
Study summary
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Baseline up to 30 days after last dose of study drug administration (up to approximately 18 years)
- Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction — Baseline up to 30 days after last dose of study drug administration (up to approximately 18 years)
Trial sites (179)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | |
| Can Care Assoc Med Group Inc | Redondo Beach | California | |
| Univ of Calif, San Francisco | San Francisco | California | |
| Central Coast Medical Oncology | San Luis Obispo | California | |
| UCLA Oncology Office | Santa Monica | California | |
| Stanford Cancer Institute | Stanford | California | |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | |
| Univ of Colorado Canc Ctr | Aurora | Colorado | |
| University of Colorado | Aurora | Colorado | |
| Rocky Mountain Cancer Center - Denver | Denver | Colorado | |
| Christina Care Institutional Review Board | Newark | Delaware | |
| Florida Cancer Specialists | Fort Myers | Florida | |
| Memorial Cancer Institute at Memorial West | Pembroke Pines | Florida | |
| Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building) | St. Petersburg | Florida | |
| Florida Cancer Specialists - Tampa (Dr. MLK Blvd) | Tampa | Florida | |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | |
| Kootenai Cancer Center | Post Falls | Idaho | |
| Loyola University Med Center | Maywood | Illinois | |
| Illinois Cancer Care | Peoria | Illinois | |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | |
| Hematology-Oncology | Bettendorf | Iowa | |
| Oncology Assoc of Cedar Rapids | Cedar Rapids | Iowa | |
| Anne Arundel Medical Center | Annapolis | Maryland | |
| Johns Hopkins Univ Med Center | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Minnesota Oncology Hematology, Pa | Minneapolis | Minnesota | |
| University of Minnesota. | Minneapolis | Minnesota | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| Mercy Clinic Cancer & Hematology | Springfield | Missouri | |
| St. John's Mercy Medical Ctr | St Louis | Missouri | |
| Comp Cancer Centers of Nevada | Las Vegas | Nevada | |
| St. Barnabas Health Care Sys | Livingston | New Jersey | |
| Clinical Research Alliance | Lake Success | New York | |
| NS-Long Island Jewish Hlth Sys | Lake Success | New York | |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | |
| The Mark H. Zangmeister Ctr | Columbus | Ohio | |
| Northwest Cancer Specialists - Portland (N Broadway) | Portland | Oregon | |
| Sarah Cannon Research Institute / Tennessee Oncology | Chattanooga | Tennessee |
+ 139 more sites — see the full list on the official registry below.
More Genentech, Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT00781612 on ClinicalTrials.gov ↗ ← All trials in South Korea