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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study
* Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)
* Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
* Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab, trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period
* Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period
Exclusion Criteria:
* AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
* Ongoing SAEs from the parent study
* Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
* Peripheral neuropathy of Grade greater than or equal to (\>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study
* History of symptomatic congestive heart failure (\[CHF\]; New York Heart Association \[NYHA\] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
* Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
* Current severe, uncontrolled systemic disease (for example \[e.g.\] clinically significant cardiovascular, pulmonary, or metabolic disease)
* Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
* Current pregnancy or lactation
* History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
* History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
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.
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.
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