Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
An Extension Study of T-DM1 in Patients Previously Treated With TDM-1
This study is enrolling participants by invitation only.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00781612
  Purpose

This is a multicenter, open-label extension study. Patients receiving T-DM1 in a Genentech-sponsored study who completed the parent study or who continue to receive T-DM1 at the time of the parent study closure are eligible for continued treatment on this protocol. The dose and schedule of T-DM1 administered will be that given in the parent study. Patients can receive T-DM1 until disease progression or unacceptable toxicity for as long as the extension study remains open. Patients randomized to non-T-DM1-containing treatment arms of T-DM1 trials are not eligible for this study.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: trastuzumab-MCC-DM1
Phase II

Genetics Home Reference related topics: breast cancer myotonic dystrophy
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title: An Open Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) in Patients Previously Treated With T-DM1 in a Genentech Sponsored T-DM1 Study

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of adverse events leading to T-DM1 discontinuation or dose reduction [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Incidence of all adverse events and serious adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: trastuzumab-MCC-DM1
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 T-DM1 treatment on the parent study or who continue to receive T-DM1 at the time of the parent study closure
  • Expectation by the investigator that the patient may continue to benefit from additional T-DM1 treatment
  • For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study. For men, agreement to use an effective form of contraception and to continue its use for the duration of the study.

Exclusion Criteria:

  • Adverse events leading to T-DM1 discontinuation in the parent study
  • Ongoing serious adverse events from the parent study
  • Progressive disease during parent study or before starting the extension study
  • Peripheral neuropathy of Grade ≥ 3 per 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, 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
  • 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 (i.e., chemotherapy, Herceptin�) since the patient's last dose in the parent study
  • History of hypersensitivity with previous T-DM1 treatment, 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

Sponsors and Collaborators
Genentech
Investigators
Study Director: Samuel Agresta, M.D., M.P.H. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: TDM4529g
Study First Received: October 27, 2008
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00781612  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
TDM1
Trastuzumab
MBC
HER2
HER2-positive breast cancer

Study placed in the following topic categories:
Myotonia atrophica
Skin Diseases
Myotonic Dystrophy
Trastuzumab
Breast Neoplasms
Dystrophia myotonica 1
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009