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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Genentech, Inc.
Sponsor:
Collaborator:
F. Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00781612
First received: October 27, 2008
Last updated: March 14, 2017
Last verified: March 2017

October 27, 2008
March 14, 2017
October 31, 2008
December 30, 2022   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last study drug administration (approximately 14 years) ]
  • Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction [ Time Frame: Baseline up to 30 days after last study drug administration (approximately 14 years) ]
  • Incidence of adverse events leading to T-DM1 discontinuation or dose reduction [ Time Frame: Length of study ]
  • Incidence of all adverse events and serious adverse events [ Time Frame: Length of study ]
Complete list of historical versions of study NCT00781612 on ClinicalTrials.gov Archive Site
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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
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech And/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study
This is a global, multicenter, open-label extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment in this study.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Docetaxel will be administered as per local prescribing information.
  • Drug: Paclitaxel
    Paclitaxel will be administered as per local prescribing information.
  • Drug: 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).
    Other Name: Perjeta
  • Drug: Trastuzumab
    Trastuzumab will be administered as per local prescribing information.
    Other Name: Herceptin
  • Drug: 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).
    Other Name: Kadcyla; T-DM1
  • Drug: Capecitabine
    Capacitabine will be administered as per local prescribing information.
    Other Name: Xeloda
Experimental: Trastuzumab Emtansine
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (Pertuzumab, paclitaxel, trastuzumab, docetaxel, and capecitabine). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.
Interventions:
  • Drug: Docetaxel
  • Drug: Paclitaxel
  • Drug: Pertuzumab
  • Drug: Trastuzumab
  • Drug: Trastuzumab Emtansine
  • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
February 28, 2023
December 30, 2022   (Final data collection date for primary outcome measure)

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 scheduled dose of study therapy on the extension study or Continue to receive treatment in the control arm of study 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 scheduled dose of control arm study therapy in the extension study
  • Participants in the control arm from Study TDM4450g whose disease progression (PD) 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 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 7 months after the last dose of study treatment
  • Male participants whose partners are pregnant should use condoms for the duration of the pregnancy

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 PD 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 or 4.0, 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 (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
United States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Guatemala,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Mexico,   New Zealand,   Norway,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovenia,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom
 
 
NCT00781612
TDM4529g
BO25430 ( Other Identifier: Hoffmann-La Roche )
2010-021067-32 ( EudraCT Number )
No
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Genentech, Inc.
Genentech, Inc.
F. Hoffmann-La Roche
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP