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

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-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

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
c) 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
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
a) No prior lines of therapy for advanced/MBC allowed
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 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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

Study & Design

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