Breast Cancer Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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. The local HER2 result must be from a tumour sample obtained in the metastatic setting.
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

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)

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

450

Study ID:

NCT04538742

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 101 Locations for this study

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Research Site
West Hollywood California, 90048, United States
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Fort Myers Florida, 33901, United States
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Saint Petersburg Florida, 33705, United States
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Baton Rouge Louisiana, 70809, United States
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Saint Paul Minnesota, 55101, United States
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Basking Ridge New Jersey, 07920, United States
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Middletown New Jersey, 07748, United States
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Montvale New Jersey, 07645, United States
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Commack New York, 11725, United States
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Harrison New York, 10604, United States
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Long Island City New York, 11101, United States
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New York New York, 10016, United States
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New York New York, 10065, United States
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Uniondale New York, 11553, United States
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Durham North Carolina, 27710, United States
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Cincinnati Ohio, 45219, United States
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Columbus Ohio, 43219, United States
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Providence Rhode Island, 02903, United States
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Nashville Tennessee, 37203, United States
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Fort Worth Texas, 76104, United States
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Fairfax Virginia, 22031, United States
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Melbourne , 3000, Australia
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Barretos , 14784, Brazil
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Belo Horizonte , 30150, Brazil
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Natal , 59075, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 91350, Brazil
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Rio de Janeiro , 20560, Brazil
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Sao Paulo , 01317, Brazil
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Sao Paulo , 04029, Brazil
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Sorocaba , 18030, Brazil
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Edmonton Alberta, T6G 1, Canada
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Montreal Quebec, H2X 0, Canada
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Montreal Quebec, H3T 1, Canada
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Quebec , G1S 4, Canada
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Toronto , M5G 2, Canada
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Dijon , 21079, France
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Marseille , 13273, France
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Villejuif Cedex , 94805, France
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Berlin , 12200, Germany
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Bottrop , 46236, Germany
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Düsseldorf , 40225, Germany
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Erlangen , 91054, Germany
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Halle , 6120, Germany
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München , 80637, Germany
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München , 81675, Germany
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Recklinghausen , 45659, Germany
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Würzburg , 97080, Germany
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Delhi , 11008, India
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Gurgaon , 12200, India
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Madurai , 62510, India
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Mumbai , 40001, India
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Mumbai , 40005, India
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Bologna , 40138, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Rome , 168, Italy
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Busan , 49241, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Bydgoszcz , 85-79, Poland
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Koszalin , 75-58, Poland
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Lublin , 20-09, Poland
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Rzeszów , 35-05, Poland
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Warszawa , 02-03, Poland
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Łódź , 90-24, Poland
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Moscow , 10522, Russian Federation
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Moscow , 10924, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 11799, Russian Federation
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Moscow , 12120, Russian Federation
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Moscow , 14342, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Sankt-Peterburg , 19660, Russian Federation
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Sankt-Peterburg , 19775, Russian Federation
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Barcelona , 08003, Spain
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L'Hospitalet de Llobregat , 08908, Spain
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Madrid , 28007, Spain
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Madrid , 28050, Spain
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Sevilla , 41013, Spain
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Hualien , 970, Taiwan
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Tainan , 704, Taiwan
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Taipei City , 114, Taiwan
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Taipei , 10048, Taiwan
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Taipei , 10449, Taiwan
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Taipei , 11217, Taiwan
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Taipei , 235, Taiwan
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Taoyuan City , 333, Taiwan
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Ankara , 6100, Turkey
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Edirne , 22030, Turkey
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Istanbul , 34662, Turkey
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Istanbul , 34722, Turkey
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Izmir , 35100, Turkey
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Buckhurst Hill , IG9 5, United Kingdom
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Cambridge , CB2 2, United Kingdom
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Glasgow , G12 0, United Kingdom
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London , EC1A , United Kingdom
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London , SE19R, United Kingdom
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Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

450

Study ID:

NCT04538742

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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