Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03734029

Collaborator

Daiichi Sankyo Co., Ltd. (Industry), AstraZeneca (Industry)

557

Enrollment

208

Locations

Arms

48.2

Anticipated Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare DS-8201a to physician choice standard treatment.

Participants must have HER2-low breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation
Has spread to other parts of the body

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Trastuzumab deruxtecan (DS-8201a) Drug: Capecitabine Drug: Eribulin Drug: Gemcitabine Drug: Paclitaxel Drug: Nab-paclitaxel	Phase 3

Detailed Description

This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.

The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

Study Design

Study Type:

Interventional

Actual Enrollment :

557 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel model, randomized at a 2:1 ratioParallel model, randomized at a 2:1 ratio

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Actual Study Start Date :

Dec 27, 2018

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Drug: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously Other Names: DS-8201a
Active Comparator: Physician's Choice HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: Capecitabine Eribulin Gemcitabine Paclitaxel Nab-paclitaxel	Drug: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Drug: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Drug: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Drug: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Drug: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Arm

Intervention/Treatment

Experimental: Trastuzumab deruxtecan

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a

Drug: Trastuzumab deruxtecan (DS-8201a)

DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously

Other Names:

DS-8201a

Active Comparator: Physician's Choice

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: Capecitabine Eribulin Gemcitabine Paclitaxel Nab-paclitaxel

Drug: Capecitabine