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

NCT04494425

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Advanced or Metastatic Breast Cancer

Interventions: Trastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 105 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Patients must be ≥18 years of age
* Pathologically documented breast cancer that:

  1. is advanced or metastatic
  2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
  3. has HER2-low or HER2 IHC \>0 \<1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
  4. was never previously HER2-positive
  5. 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:

  1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
  2. 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

Key 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
* Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current 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
* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)
Locations (293)
  • Scottsdale, Arizona, United States
  • Springdale, Arkansas, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Lakewood, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Summit, New Jersey, United States
  • Westbury, New York, United States
  • Columbus, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Norfolk, Virginia, United States
  • Seattle, Washington, United States
  • Madison, Wisconsin, United States
  • Buenos Aires, Argentina
  • CABA, Argentina
  • CABA, Argentina
  • + 263 more on CT.gov