T-DXd vs T-DM1 for HER2-Positive Breast Cancer

Recruiting in Palo Alto (17 mi)

+170 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial compares two drugs, DS-8201a and T-DM1, for treating a specific type of breast cancer that hasn't responded to other treatments. These drugs work by targeting a protein on cancer cells to deliver a toxic substance that kills the cancer. T-DM1 has shown significant improvements in patients with HER2-positive breast cancer who have not responded to previous treatments.

Research Team

Global Team Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

This trial is for adults with HER2-positive, unresectable or metastatic breast cancer who have previously been treated with trastuzumab and taxane. They must have adequate organ function and agree to use effective contraception. Those with symptomatic brain metastases, a history of certain lung conditions, uncontrolled heart disease, or previous anti-HER2 ADC treatment in the metastatic setting are excluded.

Inclusion Criteria

My kidney and liver are functioning well.

I am legally considered an adult in my country.

My cancer is confirmed HER2-positive by specific guidelines.

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Exclusion Criteria

I have or had lung inflammation that needed steroids, or it might be seen in my recent lung scans.

I have untreated, symptomatic brain or spinal cord metastases requiring medication.

I have been treated with an anti-HER2 drug for cancer that has spread.

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Treatment Details

Interventions

Ado-trastuzumab emtansine (T-DM1) (Monoclonal Antibody)
Trastuzumab deruxtecan (DS-8201a) (Antibody-drug conjugate)
Trastuzumab deruxtecan (T-DXd) (Antibody-drug conjugate)

Trial OverviewThe study compares DS-8201a (Trastuzumab deruxtecan) against T-DM1 (Ado-trastuzumab emtansine) in terms of tumor control and overall safety for patients with advanced HER2-positive breast cancer that has not responded to initial treatments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Trastuzumab deruxtecan (T-DXd)Experimental Treatment1 Intervention

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).

Group II: Ado-trastuzumab emtansine (T-DM1)Active Control1 Intervention

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.