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

Phase 3

Completed

• Conditions: nresectable/metastatic breast cancer with HER2-low expression

• Registration Number: JPRN-jRCT2080224162
• Lead Sponsor: DAIICHI SANKYO CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

1.Men or women >=20 years old (Japan).
2.Has pathologically documented breast cancer that:
a.Is unresectable or metastatic
b.Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
c.Is HR-positive or HR-negative
d.Has progressed on, and would no longer benefit from, endocrine therapy
e.Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
3.Has documented radiologic progression (during or after most recent treatment)
4.Has adequate tumor samples available or is willing to provide fresh biopsies prior to randomization for:
a.assessment of HER2 status
b.assessment of post-treatment status
5.Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
6.Has at least 1 protocol-defined measurable lesion
7.Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
8. If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months for male subjects or 7 months for female subjects after treatment

Exclusion Criteria

1.Is ineligible for all options in the physician's choice arm
2.Has breast cancer ever assessed with high-HER2 expression
3.Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
4.Has uncontrolled or significant cardiovascular disease
5.Has spinal cord compression or clinically active central nervous system metastases
6.Has history, current, or suspicion of interstitial lung disease/pneumonitis
7.Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified