Trastuzumab Emtansine Safety for Cancer

Recruiting in Palo Alto (17 mi)

+279 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

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.

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

I am willing to use effective birth control during and after the study.

I was in a control group for a previous study and my condition worsened, now I can start a new treatment.

My doctor believes I could benefit from more trastuzumab emtansine treatment.

See 2 more

Exclusion Criteria

Inability or unwillingness to comply with the protocol requirements

I do not have any severe, uncontrolled illnesses.

I have not had major surgery or a serious injury in the last 28 days.

See 9 more

Treatment Details

Interventions

Pertuzumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)
Trastuzumab Emtansine (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.