A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
DB-07
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)
3 other identifiers
interventional
245
15 countries
72
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2020
Longer than P75 for phase_1
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedStudy Start
First participant enrolled
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
ExpectedDecember 8, 2025
December 1, 2025
4.1 years
August 31, 2020
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Occurrence of adverse events (AEs)- Part 1
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 53 months
Occurrence of serious adverse events (SAEs)- Part 1
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 53 months
Occurrence of adverse events (AEs)- Part 2
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 53 months
Occurrence of serious adverse events (SAEs)- Part 2
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 53 months
Secondary Outcomes (13)
Objective Response Rate (ORR)- Part 1 and Part 2
Until progression, assessed up to approximately 53 months
Progression Free Survival (PFS)- Part 1 and Part 2
Until progression, assessed up to approximately 53 months
Progression Free Survival 2 (PFS2)- Part 2
Assessed up to approximately 53 months
Duration of Response (DoR)- Part 2
Until progression, assessed up to approximately 53 months
Overall Survival (OS)- Part 2
Until death, assessed up to approximately 53 months
- +8 more secondary outcomes
Study Arms (8)
Module 1- T-DXd and Durvalumab
EXPERIMENTALT-DXd and Durvalumab
Module 2- T-DXd and Pertuzumab
EXPERIMENTALT-DXd and Pertuzumab
Module 3- T-DXd and Paclitaxel
EXPERIMENTALT-DXd and Paclitaxel (Arm not initiated in Part 2)
Module 4- T-DXd and Durvalumab and Paclitaxel
EXPERIMENTALT-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)
Module 0- T-DXd
EXPERIMENTALT-DXd
Module 5 - T-DXd and Tucatanib
EXPERIMENTALT-DXd and tucatinib (Arm not initiated in Part 2)
Module 6 - T-DXd and Tucatinib
EXPERIMENTALT-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)
Module 7 - T-DXd
EXPERIMENTALT-DXd monotherapy in patients with active brain metastases (Part 2 Only)
Interventions
Tucatinib administered orally (tablet) twice daily
T-DXd: administered as an IV infusion
Durvalumab: administered as an IV infusion
Paclitaxel: administered as an IV infusion
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyo Company, Limitedcollaborator
Study Sites (72)
Research Site
Fort Myers, Florida, 33901, United States
Research Site
St. Petersburg, Florida, 33705, United States
Research Site
Commack, New York, 11725, United States
Research Site
Harrison, New York, 10604, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10065, United States
Research Site
Columbus, Ohio, 43219, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Fort Worth, Texas, 76104, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Melbourne, 3000, Australia
Research Site
Barretos, 14784-400, Brazil
Research Site
Belo Horizonte, 30150-274, Brazil
Research Site
Natal, 59075-740, Brazil
Research Site
Porto Alegre, 90610-000, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Rio de Janeiro, 20560-120, Brazil
Research Site
São Paulo, 01317-001, Brazil
Research Site
São Paulo, 04029-000, Brazil
Research Site
Sorocaba, 18030-005, Brazil
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Montreal, Quebec, H2X 0A9, Canada
Research Site
Québec, Quebec, G1S 4L8, Canada
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Toronto, M5G 2M9, Canada
Research Site
Villejuif, 94805, France
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München, 81675, Germany
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Würzburg, 97080, Germany
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Delhi, 110085, India
Research Site
Gūrgaon, 122001, India
Research Site
Madurai, 625107, India
Research Site
Mumbai, 400012, India
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Bologna, 40138, Italy
Research Site
Milan, 20141, Italy
Research Site
Naples, 80131, Italy
Research Site
Rome, 168, Italy
Research Site
Bydgoszcz, 85-796, Poland
Research Site
Koszalin, 75-581, Poland
Research Site
Lodz, 90-242, Poland
Research Site
Lublin, 20-090, Poland
Research Site
Moscow, 105229, Russia
Research Site
Moscow, 109240, Russia
Research Site
Moscow, 111123, Russia
Research Site
Moscow, 115478, Russia
Research Site
Moscow, 117997, Russia
Research Site
Moscow, 121205, Russia
Research Site
Moscow, 143423, Russia
Research Site
Saint Petersburg, 195271, Russia
Research Site
Saint Petersburg, 196603, Russia
Research Site
Saint Petersburg, 197758, Russia
Research Site
Busan, 602-739, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Barcelona, 08003, Spain
Research Site
L'Hospitalet de Llobregat, 08908, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28050, Spain
Research Site
Seville, 41013, Spain
Research Site
Hualien City, 970, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 10048, Taiwan
Research Site
Taipei, 10449, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taipei, 114, Taiwan
Research Site
Taipei, 235, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Ankara, 6100, Turkey (Türkiye)
Research Site
Edirne, 22030, Turkey (Türkiye)
Research Site
Istanbul, 34662, Turkey (Türkiye)
Research Site
Istanbul, 34722, Turkey (Türkiye)
Research Site
Izmir, 35100, Turkey (Türkiye)
Research Site
Buckhurst Hill, IG9 5HX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 4, 2020
Study Start
December 28, 2020
Primary Completion
January 31, 2025
Study Completion (Estimated)
January 31, 2030
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.