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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2025
  • participants needed
    450
  • sponsor
    AstraZeneca
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Updated on 2 April 2021
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Summary

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

Description

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.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Paclitaxel, durvalumab, Pertuzumab, Tucatinib, Trastuzumab deruxtecan
Clinical Study IdentifierNCT04538742
SponsorAstraZeneca
Last Modified on2 April 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
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)
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
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