Trastuzumab Deruxtecan for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+225 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

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body

Research Team

Global Team Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

This trial is for adults with HER2-positive breast cancer that's either inoperable or has spread, and who have previously been treated with T-DM1. They must not have participated in certain other drug studies, have no serious heart disease or lung conditions, and agree to use effective contraception.

Inclusion Criteria

I agree to use effective birth control or avoid sex during the study and for months after.

My blood, kidney, and liver functions are all within normal ranges.

I am legally considered an adult in my country.

Exclusion Criteria

I was in a Daiichi Sankyo antibody drug study but my disease didn't worsen within 12 months after.

I have serious heart problems that are not under control.

I have been treated with capecitabine before.

Treatment Details

Interventions

• Trastuzumab deruxtecan (Antibody-drug conjugate)

Trial Overview The study compares a new medication called DS-8201a (Trastuzumab deruxtecan) against standard treatments like Capecitabine, Trastuzumab, and Lapatinib. It aims to see if DS-8201a is more effective for those who've had prior treatment.

Participant Groups

Group I: Trastuzumab deruxtecan (DS-8201a) Experimental Treatment 1 Intervention

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a

Group II: Lapatinib+capecitabine Active Control 2 Interventions

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Group III: Trastuzumab+capecitabine Active Control 2 Interventions

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine

Trastuzumab deruxtecan is already approved in Japan for the following indications:

Approved in Japan as Enhertu for:

• Unresectable or metastatic HER2-positive breast cancer
• Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Daiichi Sankyo Co., Ltd.

Industry Sponsor

Trials

116

Recruited

49,200+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology