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Clinical Trial 20252

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03734029

Phase: Phase III
Prinicipal Investigator:

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Study Title

A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Trial Of Ds-8201a, An Anti-Her2-Antibody Drug Conjugate (Adc), Versus Treatment Of Physicians Choice For Her2-low, Unresectable And/Or Metastatic Breast Cancer Subjects


This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants


Primary Objectives The primary objective is to compare the PFS benefit of DS-8201a to physicians choice in HER2-low, HR-positive breast cancer, based on blinded independent central review (BICR). The secondary objectives are: To investigate the efficacy of DS-8201a compared to physicians choice on the following parameters (definitions of these endpoints are included in Section 7.1.2): PFS in HR-positive subjects, based on Investigator assessment; Overall survival (OS) in HR-positive subjects; Confirmed objective response rate (ORR), based on BICR and Investigator assessment in HR-positive subjects; Duration of response (DoR), based on BICR and Investigator assessment in HRpositive subjects; PFS, OS, confirmed ORR, and DoR in all subjects, regardless of HR status; To determine PK of DS-8201a; To evaluate safety of DS-8201a compared to physician¿s choice; To evaluate Health Economics and Outcomes Research (HEOR) endpoints for DS-8201a compared to physicians choice




DS-8201a (); Eribulin (); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Taxol (paclitaxel); Xeloda (capecitabine); capecitabine (); gemcitabine (); paclitaxel ()

Inclusion Criteria

  • Age 18 years or older
  • 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 (f) Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
  • Has documented radiologic progression (during or after most recent treatment)
  • Has adequate archival tumor samples available or is willing to provide fresh biopsies prior to randomization for: assessment of HER2 status, assessment of post-treatment status
  • Has at least 1 protocol-defined measurable lesion
  • Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions Male and female participants of reproductive/childbearing potential, agree to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

  • Exclusion Criteria

  • Is ineligible for all options in the physician's choice arm
  • Has breast cancer ever assessed with high-HER2 expression
  • Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
  • Has uncontrolled or significant cardiovascular disease
  • Has spinal cord compression or clinically active central nervous system metastases
  • Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

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