- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042701
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This phase 1b, open-label, 2-part, multicenter, non-randomized, multiple-dose study will evaluate DS-8201a in combination with pembrolizumab in participants with advanced/metastatic breast cancer or non-small cell lung cancer (NSCLC).
In the dose escalation part of the study, escalating doses of DS-8201a in combination with pembrolizumab will be assessed. DS-8201a and pembrolizumab 200 mg will be administered on Day 1 of every 21-day cycle. The initial dose administered for DS8201a will be 3.2 mg/kg Q3W. Escalation to the next dose (5.4 mg/kg Q3W) will be based on acceptable safety signals based on the earlier dose cohort.
Upon completion of dose escalation with the recommended dose of escalation (RDE) established, the dose expansion part of the study will begin. The dose expansion part will include 4 cohorts: Human epidermal growth factor receptor 2 (HER2+) breast cancer participants with prior ado-trastuzumab emtansine (T-DM1), HER2 low breast cancer participants with prior failed standard treatments, HER2-expressing NSCLC participants who have not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents, and HER2-mutant NSCLC participants who have not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Daiichi Sankyo Contact for Clinical Trial Information
- Phone Number: 908-992-6400
- Email: CTRinfo@dsi.com
Study Contact Backup
- Name: AZ Breast Cancer Study Navigators
- Phone Number: +1-877-400-4656
- Email: AstraZeneca@CareboxHealth.com
Study Locations
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Bordeaux, France, 33000
- Recruiting
- Institut Bergonié
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Contact:
- Principal Investigator
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Créteil, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
-
Contact:
- Principal Investigator
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Marseille, France, 13385
- Recruiting
- CHU Timone
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Contact:
- Principal Investigator
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Marsielle, France, 13273
- Recruiting
- Institut Paoli-Calmettes
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Contact:
- Principal Investigator
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Poitiers, France, 86000
- Recruiting
- CHU De Poitiers
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Contact:
- Principal Investigator
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Toulouse, France, 31100
- Recruiting
- University Cancer Institute Toulouse
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Contact:
- Principal Investigator
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Villejuif, France, 94800
- Recruiting
- Gustave Roussy
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Contact:
- Principal Investigator
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A Coruña, Spain, 15006
- Recruiting
- Hospital Teresa Herrera (C.H.U.A.C)
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Contact:
- Principal Investigator
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Barcelona, Spain, 08025
- Recruiting
- Hospital de la Santa Creu i de Sant Pau
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Contact:
- Principal Investigator
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Barcelona, Spain, 08023
- Recruiting
- Institute Oncologico Baselga Hospital Quiron
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Contact:
- Principal Investigator
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Contact:
- Principal Investigator
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Madrid, Spain, 28033
- Recruiting
- MD Anderson Cancer Center
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Contact:
- Principal Investigator
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Madrid, Spain, 28009
- Recruiting
- Hospital General Universitario Gregorio Maranon
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Contact:
- Principal Investigator
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Sevilla, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
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Contact:
- Principal Investigator
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
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Contact:
- Principal Investigator
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London, United Kingdom, SW3 6JJ
- Recruiting
- The Royal Marsden NHS Foundation Trust
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Contact:
- Principal Investigator
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London, United Kingdom, W1G 6AD
- Recruiting
- Sarah Cannon Research Institute (SCRI)
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Contact:
- Principal Investigator
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
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Contact:
- Principal Investigator
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Sutton, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital
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Contact:
- Principal Investigator
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Wirral, United Kingdom, CH63 4JY
- Withdrawn
- Clatterbridge Cancer Centre
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California
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San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco Medical Center
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Contact:
- Principal Investigator
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Florida
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Jacksonville, Florida, United States, 322256
- Recruiting
- Cancer Specialists of North Florida
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Contact:
- Principal Investigator
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Tampa, Florida, United States, 33612
- Recruiting
- Moffit Cancer Center
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Contact:
- Principal Investigator
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Maryland
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Bethesda, Maryland, United States, 20817
- Recruiting
- Center for Cancer & Blood Disorders
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Contact:
- Principal Investigator
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Completed
- Massachusetts General Hospital Cancer Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Completed
- Siteman Cancer Center-Washington University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Fox Chase Cancer Center
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Contact:
- Principal Investigator
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Texas
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Tyler, Texas, United States, 75701
- Recruiting
- HOPE Cancer Center of East Texas
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Contact:
- Principal Investigator
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent
- Adults ≥18 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- Pathologically documented HER2-expressing locally advanced/metastatic breast cancer, and HER2-expressing or HER2-mutant locally advanced/metastatic NSCLC
- Willing to provide a tumor biopsy during screening and during treatment
- Have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator
- Adequate cardiac function, as defined by left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment.
- Adequate organ function
- Adequate treatment washout period before enrollment
Inclusion Criteria Specific to Part 1
- Participants in Part 1 should meet the additional inclusion criteria listed for 1 of the 4 cohorts in Part 2.
Inclusion Criteria Specific to Part 2
Inclusion Criteria for Cohort 1
- Pathologically documented, locally advanced/metastatic breast cancer that has centrally determined HER2-positive expression as per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) Guidelines
- Received prior trastuzumab emtansine (T-DM1) therapy with documented progression
Inclusion Criteria for Cohort 2
- Pathologically documented, locally advanced/metastatic breast cancer that has centrally determined HER2-low expression (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH-])
- Participants must have exhausted treatments that can confer any clinically meaningful benefit (eg, other therapies such as hormonal therapy for participants who are hormone receptor positive)
Inclusion Criteria for Cohort 3
- Pathologically documented, locally advanced/metastatic NSCLC that has centrally or locally determined HER2-expression (IHC 1+, 2+, or 3+)
- Participants who have known epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK), BRAF V600E mutation, or ROS1 fusion should have disease progression after treatment with at least one genomically-targeted therapy for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment
Inclusion Criteria for Cohort 4
- Pathologically documented, locally advanced/metastatic HER2-mutant NSCLC
- Participants who have known EGFR mutation, ALK, BRAF V600E mutation, or ROS1 fusion should have disease progression after treatment with at least one genomically-targeted therapy for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment
Exclusion Criteria:
- Prior treatment with pembrolizumab or DS-8201a
- Medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before enrollment to rule out MI
- Corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (males)
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Spinal cord compression or clinically active central nervous system metastases
- Active, known or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
- Prior therapy with an anti-PD-1 or anti-PD-L1 agent
- Prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
- Prior anti-HER2 therapy is not allowed for participants with HER2 low-expressing breast cancer or participants with NSCLC (Cohorts 2, 3, or 4). Prior treatment with pan-HER tyrosine kinase inhibitor is allowed.
- Prior systemic anticancer therapy, including investigational agents within 2 to 6 weeks prior to treatment
- Unresolved toxicities from previous anticancer therapy
- Live vaccine within 30 days prior to the first dose of study drug
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
- Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer
- History of severe hypersensitivity reactions to other monoclonal antibodies and/or any of the study drug components
- Active infection requiring systemic therapy
- Known history of human immunodeficiency virus (HIV) infection
- Active hepatitis B or C virus infection
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, or any other reason the participant is found not appropriate to participate in the opinion of the treating Investigator
- Known psychiatric or substance abuse disorders
- Prior organ transplantation, including allogeneic stem cell transplantation
- Pregnant, breastfeeding, or planning to become pregnant
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Uncontrolled infection requiring IV antibiotics, anti-virals, or anti-fungals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 (Dose Escalation)
HER2-positive breast cancer, HER2-low expressing breast cancer, HER2-expressing NSCLC, and HER2-mutant NSCLC participants who received escalating doses of DS8201a (initial dose 3.2 mg/kg Q3W) and pembrolizumab 200 mg.
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Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab. Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
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Experimental: HER2-positive breast cancer (Part 2 Dose Expansion)
HER2-positive breast cancer participants with prior ado-trastuzumab emtansine (T-DM1) with disease progression and who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
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Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab. Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
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Experimental: HER2-low breast cancer (Part 2 Dose Expansion)
HER2 low breast cancer participants with prior failed standard treatments who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
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Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab. Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
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Experimental: HER2-expressing NSCLC (Part 2 Dose Expansion)
HER2-expressing NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.
|
Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab. Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
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Experimental: HER2-mutant NSCLC (Part 2 Dose Expansion)
HER2-mutant NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.
|
Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab. Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicities (DLTs), Part 1
Time Frame: Within two 3-week cycles (6 weeks)
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Maximum Tolerated Dose (MTD) or recommended dose expansion (RDE) of DS-8201a (Part1) are based on the occurrence of DLTs.
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Within two 3-week cycles (6 weeks)
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Objective Response Rate (ORR), Confirmed by Independent Central Review, Part 2
Time Frame: Within approximately 30 months
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Within approximately 30 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-emergent adverse events
Time Frame: Within approximately 30 months
|
Within approximately 30 months
|
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Pharmacokinetic Parameter Maximum Serum Concentration (Cmax)
Time Frame: Cycle 1, Day 1: predose and postdose, Day 8, and Day 15; Cycle 2, Day 1 predose and postdose, and Cycle 3, Day 1 (each cycle is 21 days)
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Cmax of trastuzumab deruxtecan, MAAA-118A, and total anti-HER2 antibody will be assessed.
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Cycle 1, Day 1: predose and postdose, Day 8, and Day 15; Cycle 2, Day 1 predose and postdose, and Cycle 3, Day 1 (each cycle is 21 days)
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Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)
Time Frame: Cycle 1, Day 1: predose and postdose, Day 8, and Day 15; Cycle 2, Day 1 predose and postdose, and Cycle 3, Day 1 (each cycle is 21 days)
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Area under the concentration-time curve of trastuzumab deruxtecan, MAAA-118A, and total anti-HER2 antibody will be assessed.
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Cycle 1, Day 1: predose and postdose, Day 8, and Day 15; Cycle 2, Day 1 predose and postdose, and Cycle 3, Day 1 (each cycle is 21 days)
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Duration of Response (DoR)
Time Frame: Within approximately 30 months
|
Within approximately 30 months
|
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Disease Control Rate (DCR)
Time Frame: Within approximately 30 months
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Within approximately 30 months
|
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Progression-Free Survival (PFS), based on Independent Central Review using RECIST v1.1
Time Frame: Within approximately 30 months
|
Within approximately 30 months
|
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Time to Response (TTR), based on Independent Central Review using RECIST v1.1
Time Frame: Within approximately 30 months
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Within approximately 30 months
|
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Overall survival (OS)
Time Frame: Within approximately 30 months
|
Within approximately 30 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Topoisomerase I Inhibitors
- Trastuzumab
- Pembrolizumab
- Immunoconjugates
- Camptothecin
- Trastuzumab deruxtecan
Other Study ID Numbers
- DS8201-A-U106
- 2018-002489-38 (EudraCT Number)
- KEYNOTE KN-797 (Other Identifier: Merck Sharp & Dohme Corp)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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