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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860

Paclitaxel

2011

Completed Phase 4

~5450