Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04538742

PHASE1/PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Official title: A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore 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 (DESTINY-Breast07)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

245

Start Date

2020-12-28

Completion Date

2030-01-31

Last Updated

2025-12-08

Healthy Volunteers

Conditions

Metastatic Breast Cancer

Interventions

DRUG

Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

DRUG

Durvalumab

Durvalumab: administered as an IV infusion

DRUG

Paclitaxel

Paclitaxel: administered as an IV infusion

DRUG

Pertuzumab

Pertuzumab: administered as an IV infusion

DRUG

Tucatinib

Tucatinib administered orally (tablet) twice daily

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. The local HER2 result must be from a tumour sample obtained in the metastatic setting. 3. 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 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 at a total daily dose of \> 2 mg dexamethasone or any brain lesion thought to require immediate local therapy

Locations (72)

Research Site

Fort Myers, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Commack, New York, United States

Research Site

Harrison, New York, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Columbus, Ohio, United States

Research Site

Nashville, Tennessee, United States

Research Site

Fort Worth, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Melbourne, Australia

Research Site

Barretos, Brazil

Research Site

Belo Horizonte, Brazil

Research Site

Natal, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Rio de Janeiro, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Sorocaba, Brazil

Research Site

Montreal, Quebec, Canada

Research Site

Québec, Quebec, Canada

Research Site

Toronto, Canada

Research Site

Villejuif, France

Research Site

München, Germany

Research Site

Würzburg, Germany

Research Site

Delhi, India

Research Site

Gūrgaon, India

Research Site

Madurai, India

Research Site

Mumbai, India

Research Site

Bologna, Italy

Research Site

Milan, Italy

Research Site

Naples, Italy

Research Site

Rome, Italy

Research Site

Bydgoszcz, Poland

Research Site

Koszalin, Poland

Research Site

Lodz, Poland

Research Site

Lublin, Poland

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saint Petersburg, Russia

Research Site

Busan, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

L'Hospitalet de Llobregat, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Seville, Spain

Research Site

Hualien City, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

Research Site

Ankara, Turkey (Türkiye)

Research Site

Edirne, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Izmir, Turkey (Türkiye)

Research Site

Buckhurst Hill, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)