T-DXd +/− Pertuzumab for Breast Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

Eligibility Criteria

This trial is for adults over 18 with HER2-positive metastatic breast cancer. They should have good organ and bone marrow function, an ECOG performance status of 0 or 1, and no prior advanced/metastatic breast cancer treatment except possibly one line of endocrine therapy. Prior neo-adjuvant or adjuvant treatments are okay if it's been over 6 months.

Inclusion Criteria

I am 18 years old or older.

My breast cancer is confirmed to be advanced or has spread.

My breast cancer is confirmed to be HER2-positive.

My breast cancer is confirmed as hormone receptor positive or negative.

My organs and bone marrow are functioning well.

I am fully active or can carry out light work.

Exclusion Criteria

I am not eligible for any of the treatments being studied.

I have or had lung inflammation that's been confirmed or can't be ruled out.

Treatment Details

The study tests the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd), alone or with Pertuzumab, compared to a Taxane-based regimen including Trastuzumab and Pertuzumab as first-line treatments for metastatic HER2-positive breast cancer.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm BExperimental Treatment2 Interventions

Trastuzumab deruxtecan (T-DXd) plus pertuzumab

Group II: Arm AExperimental Treatment2 Interventions

Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo

Group III: Arm CActive Control3 Interventions

Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)

Pertuzumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Perjeta for: