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

Trial 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.

Receptor status / problem studied:

ADC targetting HER2 - low

Inclusion criteria

Patients must be ≥18 years of age

Pathologically documented breast cancer that:

  • is advanced or metastatic
  • has 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
  • disease 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

Exclusion criteria

  • Ineligible for all options in the investigator’s choice chemotherapy arm
  • Lung-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

View more trial information

Open for recruitment

Trial Title

DESTINY-Breast06

Diagnosis

Breast cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

III

Investigators

Principal Investigator
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