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A Phase 1b / 2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Trial Status: Active

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Inclusion Criteria

  • Patients must be at least 18 years of age
  • Pathologically documented breast cancer that:
  • Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
  • HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
  • Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
  • Patient must have adequate tumor sample for biomarker assessment
  • ECOG Performance Status of 0 or 1
  • Part 1
  • Disease progression on or after the last systemic therapy prior to starting study treatment
  • At least 1 prior treatment line in metastatic setting required.
  • Part 2 (Modules 0 - 5) a) No prior lines of therapy for advanced/MBC allowed
  • Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed CNS Inclusion
  • Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
  • Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy

Exclusion Criteria

  • Uncontrolled or significant cardiovascular disease
  • Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Spinal cord compression or a history of leptomeningeal carcinomatosis
  • Prior treatment with immune checkpoint inhibitors
  • Prior treatment with an ADC containing a topoisomerase I inhibitor
  • Prior treatment with tucatinib CNS Exclusion
  • Modules 0 - 5: Has untreated brain metastasis
  • Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

This study is modular in design allowing assessment of safety, tolerability and anti-tumour

activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules

will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the

recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in

Part 2.

The target population of interest in this study is patients with HER2-positive (as per

ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain

metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive

advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients

with locally assessed HER2-positive breast cancer who have not received prior treatment for

advanced/metastatic disease.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D967JC00001
  • Secondary IDs NCI-2021-04133
  • Clinicaltrials.gov ID NCT04538742