Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Trial number:
NCT04494425
Trial phase:
3
Study type:
Targeted therapy
Overall status:
Recruiting

Study start date

July, 2020

Scientific title

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

Summary

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Key

Patients must be ≥18 years of age

Pathologically documented breast cancer that:

is advanced or metastatichas a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) has HER2-low or HER2 IHC >0 <1+ expression was never previously HER2-positive is documented HR+ disease in the metastatic setting. No prior chemotherapy for advanced or metastatic breast cancer. Has adequate tumor samples for assessment of HER2 status

Must have either:

disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor ordisease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting. Has protocol-defined adequate organ and bone marrow function

Key

Ineligible for all options in the investigator's choice chemotherapy armLung-specific intercurrent clinically significant illnesses Uncontrolled or significant cardiovascular disease or infection Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening Patients with spinal cord compression or clinically active central nervous system metastases Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Intervention model description: The study consists of 2 independent open label treatment arms, Masking: None (Open Label), Masking description: This study is an open-label study that will be conducted "Sponsor-blind". To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.,

Conditions

Advanced or Metastatic Breast Cancer

Other study ID numbers

D9670C00001

Choose trial site (597)

Tan Tock Seng Hospital Singapore
Tan Tock Seng Hospital Singapore Not yet recruiting
11 Jln Tan Tock Seng, Level 1, Singapore 308433
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
Curie Oncology (Farrer)
Curie Oncology (Farrer) Recruiting