A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
NCT ID: NCT04538742
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
245 participants
INTERVENTIONAL
2020-12-28
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 1- T-DXd and Durvalumab
T-DXd and Durvalumab
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Durvalumab
Durvalumab: administered as an IV infusion
Module 2- T-DXd and Pertuzumab
T-DXd and Pertuzumab
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Pertuzumab
Pertuzumab: administered as an IV infusion
Module 3- T-DXd and Paclitaxel
T-DXd and Paclitaxel (Arm not initiated in Part 2)
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Paclitaxel
Paclitaxel: administered as an IV infusion
Module 4- T-DXd and Durvalumab and Paclitaxel
T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Durvalumab
Durvalumab: administered as an IV infusion
Paclitaxel
Paclitaxel: administered as an IV infusion
Module 0- T-DXd
T-DXd
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Module 5 - T-DXd and Tucatanib
T-DXd and tucatinib (Arm not initiated in Part 2)
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Tucatinib
Tucatinib administered orally (tablet) twice daily
Module 6 - T-DXd and Tucatinib
T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Tucatinib
Tucatinib administered orally (tablet) twice daily
Module 7 - T-DXd
T-DXd monotherapy in patients with active brain metastases (Part 2 Only)
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Interventions
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Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Durvalumab
Durvalumab: administered as an IV infusion
Paclitaxel
Paclitaxel: administered as an IV infusion
Pertuzumab
Pertuzumab: administered as an IV infusion
Tucatinib
Tucatinib administered orally (tablet) twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Daiichi Sankyo Company, Limited
UNKNOWN
Responsible Party
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Locations
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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
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New York, New York, United States
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New York, New York, United States
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Columbus, Ohio, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Fairfax, Virginia, United States
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Melbourne, , Australia
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Barretos, , Brazil
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Belo Horizonte, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Toronto, , Canada
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Villejuif, , France
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München, , Germany
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Würzburg, , Germany
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Delhi, , India
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Gurgaon, , India
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Madurai, , India
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Mumbai, , India
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Bologna, , Italy
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Milan, , Italy
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Napoli, , Italy
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Rome, , Italy
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Bydgoszcz, , Poland
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Koszalin, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
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Busan, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
Madrid, , Spain
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Madrid, , Spain
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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
Countries
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Related Links
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Related Info
Other Identifiers
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2023-505309-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004531-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D967JC00001
Identifier Type: -
Identifier Source: org_study_id
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