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

Running, not enrolling · Phase 2

Conditions studied: Neoplasm Metastasis

In brief

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.

Key facts

Study ID: NCT00781612
Run by: Genentech, Inc.
People needed: 720
Starts: 2008-10-16
Expected to finish: 2030-04-30
Last updated by the study team: 2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Can Care Assoc Med Group Inc — Redondo Beach, California, United States
Univ of Calif, San Francisco — San Francisco, California, United States
Central Coast Medical Oncology — San Luis Obispo, California, United States
UCLA Oncology Office — Santa Monica, California, United States
Stanford Cancer Institute — Stanford, California, United States
Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
Univ of Colorado Canc Ctr — Aurora, Colorado, United States
University of Colorado — Aurora, Colorado, United States
Rocky Mountain Cancer Center - Denver — Denver, Colorado, United States
Christina Care Institutional Review Board — Newark, Delaware, United States
Florida Cancer Specialists — Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial West — Pembroke Pines, Florida, United States
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building) — St. Petersburg, Florida, United States
Florida Cancer Specialists - Tampa (Dr. MLK Blvd) — Tampa, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
Kootenai Cancer Center — Post Falls, Idaho, United States
Loyola University Med Center — Maywood, Illinois, United States
Illinois Cancer Care — Peoria, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
Hematology-Oncology — Bettendorf, Iowa, United States
Oncology Assoc of Cedar Rapids — Cedar Rapids, Iowa, United States
Anne Arundel Medical Center — Annapolis, Maryland, United States
Johns Hopkins Univ Med Center — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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