T-DXd vs. T-DM1 for Residual Breast Cancer

Recruiting in Palo Alto (17 mi)

+486 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Daiichi Sankyo

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Eligibility Criteria

This trial is for adults over 18 with HER2-positive breast cancer who didn't have a complete response after neoadjuvant therapy. They should have had surgery to remove the disease, not be stage IV, and must not have received certain drugs like T-DXd or T-DM1 before. Participants need good heart function and no history of severe lung or heart conditions.

Inclusion Criteria

Your heart's pumping function (LVEF) is at least 50% within the last 28 days before joining the study.

My breast cancer has been confirmed by a biopsy.

I still have cancer in my breast or lymph nodes after initial treatment.

+14 more

Exclusion Criteria

I have had breast cancer before, but not LCIS.

I have had lung inflammation that needed steroids, or it shows on a chest CT scan.

I haven't had a heart attack or severe heart failure in the last 6 months.

+7 more

Participant Groups

The study compares Trastuzumab Deruxtecan (T-DXd) with Trastuzumab Emtansine (T-DM1) in patients at high risk of recurrence after initial treatment for invasive breast cancer. It aims to find out which drug is safer and more effective as a follow-up therapy.

2Treatment groups

Experimental Treatment

Active Control

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

Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.

Group II: Trastuzumab ematansine (T-DM1)Active Control1 Intervention

Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.