Safety Extension Study for Patients Previously Treated with Trastuzumab Emtansine Alone or with Other Cancer Therapies

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT00781612

This study allows patients who were benefiting from trastuzumab emtansine treatment in a previous study to continue receiving the medication. It aims to ensure the ongoing safety and effectiveness of the treatment for those who were part of earlier research.

Patient Parameters

Program Overview

This global study is designed for patients who were receiving trastuzumab emtansine, either alone or with other cancer treatments, in a previous study sponsored by Genentech/Roche. If these patients were benefiting from the treatment when the previous study ended, they can continue their treatment in this extension study to further evaluate its safety.

Eligibility Criteria

Inclusion Criteria

  • Completed or are currently receiving trastuzumab emtansine treatment in a previous study and had their last dose within 6 weeks before starting this extension study.
  • Were in the control group of a specific previous study and had disease progression during the transition to this extension study.
  • The study doctor believes the patient may continue to benefit from the treatment.
  • Women who can become pregnant and men with partners who can become pregnant must use effective non-hormonal birth control during the study and for several months after the last dose.
  • Men with pregnant partners should use condoms during the pregnancy and should not donate sperm during this time.

Exclusion Criteria

  • Had side effects in the previous study that led to stopping trastuzumab emtansine treatment.
  • Have ongoing serious side effects from the previous study.
  • Experienced disease progression on trastuzumab emtansine treatment in the previous study, except for certain cases.
  • Have severe nerve damage or heart problems.
  • Have severe breathing difficulties or need continuous oxygen therapy.
  • Have uncontrolled serious health conditions.
  • Had major surgery or a significant injury within 28 days before joining this study.
  • Are currently pregnant or breastfeeding.
  • Have received other cancer treatments since the last dose in the previous study.
  • Have allergies to trastuzumab emtansine or related treatments.
  • Are unable or unwilling to follow the study requirements.

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