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Clinical Trials in the UK / NCT00781612
Active, not recruiting Phase 2

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

NCT00781612 · tracked via the Priya Life Science UK tracker
Sponsor
Genentech, Inc.
Phase
Phase 2
Started
2008-10-16
Last updated
2026-08-28

Condition(s) studied

Neoplasm Metastasis

Investigational drug(s) / intervention(s)

DocetaxelPaclitaxelPertuzumabTrastuzumabTrastuzumab EmtansineAtezolizumab

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)

Trial sites (179)

FacilityCityRegionStatus
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.

On this site

📄 Herceptin (trastuzumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile →

More Genentech, Inc. trials in the UK

Other trials for the same condition

Official registry record

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 the UK