Trastuzumab Emtansine Safety for Cancer
Trial Summary
What is the purpose of this trial?
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss your current medications with the study team to get a clear answer.
What data supports the effectiveness of the drug Trastuzumab Emtansine (T-DM1) for cancer?
Trastuzumab Emtansine (T-DM1) has been shown to improve survival in patients with HER2-positive metastatic breast cancer, as demonstrated in the EMILIA trial, where it was compared to other standard treatments. It is generally well tolerated, although some patients may need dose adjustments due to side effects.12345
Is Trastuzumab Emtansine generally safe for humans?
Trastuzumab Emtansine (also known as T-DM1 or Kadcyla) has been studied for safety in treating HER2-positive breast cancer. While it is generally considered safe, it can cause side effects, including serious ones like lung problems, as seen in a case of fatal pneumonia. It's important to discuss potential risks with a healthcare provider.15678
How is the drug Trastuzumab Emtansine (Kadcyla) different from other treatments for HER2-positive breast cancer?
Trastuzumab Emtansine (Kadcyla) is unique because it combines an antibody (trastuzumab) with a chemotherapy drug (emtansine) to specifically target and kill cancer cells, which may result in fewer side effects compared to traditional chemotherapy. It is used for HER2-positive breast cancer that has not responded to other treatments, offering a targeted approach that can be more effective for certain patients.14569
Research Team
Clinical Trials
Principal Investigator
Genentech, Inc.
Eligibility Criteria
This trial is for cancer patients who were previously treated with Trastuzumab Emtansine alone or in combination with other therapies in a related study and are still benefiting. They must not have severe heart issues, uncontrolled diseases, recent major surgeries, current pregnancy/lactation, certain drug allergies, high-grade peripheral neuropathy, or specific adverse reactions from previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trastuzumab emtansine as a single agent or in combination with other anti-cancer therapies in 21-day cycles or weekly, depending on the schedule used in the parent study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive treatment as long as they are benefiting from it
Treatment Details
Interventions
- Pertuzumab
- Trastuzumab
- Trastuzumab Emtansine
Trastuzumab Emtansine is already approved in United States, European Union, United Kingdom for the following indications:
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
- Adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
- Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
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Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University