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Monoclonal Antibodies

Trastuzumab Emtansine Safety for Cancer

Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Severe, uncontrolled systemic disease
Major surgical procedure or significant traumatic injury within 28 days prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is for people who have been receiving treatment with either trastuzumab emtansine or a combination of it with other anti-cancer therapies, and who are still benefiting from the treatment. The purpose of the trial is to continue to monitor the safety of the treatment.

Who is the study for?
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.
What is being tested?
The trial continues treatment with Trastuzumab Emtansine for those showing benefits from prior studies. It's an open-label extension meaning everyone knows what treatment they're getting. The aim is to assess long-term safety of the drug used alone or with other anti-cancer agents like Paclitaxel and Atezolizumab.
What are the potential side effects?
Possible side effects include allergic reactions to medication components, liver problems indicated by yellow skin/eyes (jaundice), tiredness (fatigue), nausea/vomiting, low blood cell counts leading to increased infection risk or bleeding tendencies, nerve damage causing numbness/pain (neuropathy), and heart issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe, uncontrolled illnesses.
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I have not had major surgery or a serious injury in the last 28 days.
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My cancer has worsened despite being on trastuzumab emtansine.
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I have not taken any experimental cancer treatments since my last study drug dose.
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I have severe nerve pain or tingling.
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I have severe trouble breathing or need oxygen all the time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trastuzumab EmtansineExperimental Treatment6 Interventions
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5850
Paclitaxel
2011
Completed Phase 4
~5810
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190
Docetaxel
1995
Completed Phase 4
~5620
Trastuzumab Emtansine
2016
Completed Phase 3
~5730

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,550 Previous Clinical Trials
567,644 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,444 Previous Clinical Trials
1,092,402 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,212 Previous Clinical Trials
891,696 Total Patients Enrolled

Media Library

Trastuzumab Emtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00781612 — Phase 2
Cancer Research Study Groups: Trastuzumab Emtansine
Cancer Clinical Trial 2023: Trastuzumab Emtansine Highlights & Side Effects. Trial Name: NCT00781612 — Phase 2
Trastuzumab Emtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00781612 — Phase 2
~172 spots leftby Sep 2029
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