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

• Status: Recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo Company, Limited
• Treatments: Durvalumab; Paclitaxel; Pertuzumab; Trastuzumab; Tucatinib

Criteria

Key Inclusion Criteria:

• Patients must be at least 18 years of age

• Pathologically documented breast cancer that:

1. Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic

2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment

3. 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

1. Disease progression on or after the last systemic therapy prior to starting study treatment

2. 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

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 or brain lesion thought to require immediate local therapy