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SCCA Breast Cancer Clinical Trials

Extension Study of T-DM1 in Patients Previously Treated With T-DM1 (UW10039)
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 (UW10039)
Status Conditions Phase Study ID
Closed Metastatic Breast Cancer Phase II UW10039
NCT00781612
Summary

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.


Investigator
Julie R. Gralow, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Completed single-agent T-DM1 or combination T-DM1 treatment on the parent study or who continue to receive single-agent T-DM1 or combination T-DM1 treatment at the time of the parent study closure
  • Expectation by the investigator that the patient may continue to benefit from additional single-agent T-DM1 or combination T-DM1 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 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.
Exclusions (conditions that would prevent participation in this study)
  • Adverse event(s) leading to single-agent T-DM1 or combination T-DM1 treatment discontinuation in the parent study
  • Ongoing serious adverse event(s) from the parent study
  • Progressive disease on single-agent T-DM1 or a T-DM1-containing regimen during parent study or before starting the extension study, with the exception of patients from study TDM4688g with early progressive disease who went on to receive pertuzumab + T-DM1 treatment and have not experienced further disease progression on the combination regimen 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, 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
  • 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, Herceptin®, etc.) since the patient's last study drug dose in the parent study
  • History of hypersensitivity with previous T-DM1 or any agent used with T-DM1 in the parent study, precluding further dosing
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Last Updated
February 11, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.