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

  • End date
    Apr 18, 2025
  • participants needed
  • sponsor
Updated on 18 October 2021


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.


Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Condition Advanced or Metastatic Breast Cancer
Treatment Capecitabine, Paclitaxel, Nab-paclitaxel, Trastuzumab deruxtecan
Clinical Study IdentifierNCT04494425
Last Modified on18 October 2021


Yes No Not Sure

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
Has protocol-defined adequate organ and bone marrow function
disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
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

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
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