An Extension Study of Trastuzuma Emtansine in Patients Previously Treated With Trastuzuma Emtansine

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00781612
First received: October 27, 2008
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel 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 on this protocol.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab emtansine [Kadcyla]
Drug: pertuzumab [Perjeta]
Drug: paclitaxel
Drug: trastuzumab [Herceptin]
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Treated With the Equivalent T-DM1 Regimen in a Genentech and/or F. Hoffmann-La Roche Ltd.-Sponsored T-DM1 Study

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of adverse events leading to T-DM1 or combination treatment discontinuation or dose reduction [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of all adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of all serious adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: October 2008
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab emtansine [Kadcyla]
Intravenous repeating dose
Drug: pertuzumab [Perjeta]
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: trastuzumab [Herceptin]
Intravenous repeating dose
Drug: docetaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 at the time of the parent study closure if the patient 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
  • Patients in the control arm from Study 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
  • Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the patient 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
  • Patients from parent study BO25499 must be on a stable dose of trastuzumab emtansine for at least two cycles
  • 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 patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment
  • Male patients whose partners are pregnant should use condoms for the duration of the pregnancy

Exclusion Criteria:

  • Adverse event(s)leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
  • Ongoing serious adverse event(s) 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 patients from Study TDM4688g 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 >/= 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
  • 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 patient?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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781612

  Show 80 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00781612     History of Changes
Other Study ID Numbers: TDM4529g, BO25430
Study First Received: October 27, 2008
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Maytansine
Docetaxel
Trastuzumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014