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 inclusive of patients with active and stable brain metastases

Phase 1

• Conditions: HER2-positive Metastatic Breast Cancer; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004531-22-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-28
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Key Inclusion Criteria:
-Patients must be at least 18 years of age
- Pathologically documented breast cancer that:
a) Is advanced/unresectable (patients that can be treated with curative
intent are not eligible) or metastatic
b) HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment.
The local HER2 result must be from a tumour sample obtained in the
metastatic setting.
c) Is documented as hormone receptor-positive (estrogen or
progesterone receptor) or negative in the metastatic setting
-Patient must have adequate tumor sample from the metastatic setting
for biomarker assessment
-ECOG Performance Status of 0 or 1
-Part 1
a) Disease progression on or after the last systemic therapy prior to
starting study treatment
b) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Key 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 at a total daily dose of > 2 mg
dexamethasone or any brain lesion thought to require immediate local
therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified