A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
3 other identifiers
interventional
732
20 countries
167
Brief Summary
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Oct 2021
167 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
October 4, 2021
CompletedStudy Start
First participant enrolled
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2024
CompletedResults Posted
Study results publicly available
February 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedMay 5, 2026
May 1, 2026
2.8 years
October 4, 2021
July 23, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival
PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.
On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months
Overall Survival
OS is defined as time from randomization until the date of death due to any cause. The comparison will include all randomized participants as randomized, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the hazard ratio of OS.
From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Secondary Outcomes (11)
Objective Response Rate (ORR)
From date of randomization until event. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months for investigator assessment.
Duration of Response (DoR) as Assessed by BICR Assessment
From date of first response until progression or death. Tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months.
Duration of Response (DoR) as Assessed by Investigator Assessment
From date of first response until progression or death. Tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months
Progression-Free Survival by Investigator Assessment
On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months
Disease Control Rate (DCR)
Assessed up to data cut-off (17Jul2023) to a maximum of 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of 33 months for investigator assessment.
- +6 more secondary outcomes
Study Arms (2)
Dato-DXd
EXPERIMENTALArm 1: Dato-DXd
Investigators Choice of Chemotherapy (ICC)
ACTIVE COMPARATORArm 2: ICC Capecitabine Gemcitabine Eribulin mesylate Vinorelbine
Interventions
Experimental drug. Provided in 100mg vials. IV infusion.
Tablet. Oral route of administration. Active comparator
IV Infusion. Active comparator
Eligibility Criteria
You may qualify if:
- Age • Participant must be ≥ 18 years at the time of screening.
- Type of Participant and Disease Characteristics
- Inoperable or metastatic HR+, HER2-negative breast cancer
- Progressed on and not suitable for endocrine therapy per investigator assessment and treated with 1 to 2 lines of prior chemotherapy in the inoperable/metastatic setting. Participant must have documented progression on their most recent line of chemotherapy.
- Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, vinorelbine, gemcitabine), per investigator assessment.
- ECOG PS of 0 or 1, with no deterioration over the previous 2 weeks prior to day of first dosing.
- At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1. Note: Participants with bone-only metastases are not permitted.
- Participants with a history of previously treated neoplastic spinal cord compression, or clinically inactive brain metastases, who require no treatment with corticosteroids or anticonvulsants, may be included in the study, if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of radiotherapy and study enrolment.
- Adequate organ and bone marrow function within 7 days before day of first dosing as follows:
- Hemoglobin: ≥ 9.0 g/L.
- Absolute neutrophil count: 1500/mm3.
- Platelet count: 100000/mm3. • Total bilirubin: ≤ 1.5 × ULN if no liver metastases; or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
- ALT and AST: ≤ 3 × ULN for AST/ALT; however, if elevation is due to liver metastases, ≤ 5.0 × ULN is allowed.
- Calculated creatinine clearance: ≥ 30 mL/min as calculated using the Cockcroft-Gault equation (using actual body weight).
- LVEF ≥ 50% by either an echocardiogram or MUGA within 28 days of first dosing.
- +18 more criteria
You may not qualify if:
- Medical Conditions
- Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy, adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- Persistent toxicities caused by previous anticancer therapy (excluding alopecia), not yet improved to CTCAE Version 5.0 Grade ≤ 1 or baseline. Note: participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no worsening to \> Grade 2 for at least 3 months prior to first dosing and managed with SoC treatment) which the investigator deems related to previous anticancer therapy.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections.
- Known active or uncontrolled hepatitis B or C infection; or positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (HBsAg, anti-HBs, anti-HBc, or HBV DNA) or hepatitis C (HCV antibody or HCV RNA) infection at screening.
- Known HIV infection that is not well controlled.
- Uncontrolled or significant cardiac disease, including myocardial infarction or uncontrolled/unstable angina within 6 months prior to C1D1, CHF (New York Heart Association Class II to IV), uncontrolled or significant cardiac arrhythmia, or uncontrolled hypertension (resting systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg).
- Investigator judgment of 1 or more of the following:
- Mean resting corrected QTcF interval \> 470 ms , obtained from triplicate ECGs performed at screening.
- History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
- Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy.
- Leptomeningeal carcinomatosis.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyocollaborator
- AstraZenecalead
Study Sites (167)
Research Site
Duarte, California, 91010, United States
Research Site
Los Angeles, California, 90095, United States
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Palo Alto, California, 94305-5826, United States
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San Francisco, California, 94143, United States
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Jacksonville, Florida, 32207, United States
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Atlanta, Georgia, 30322, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Grand Rapids, Michigan, 49503, United States
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New York, New York, 10065, United States
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Cleveland, Ohio, 44119, United States
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Portland, Oregon, 97239, United States
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Nashville, Tennessee, 37203, United States
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Richmond, Virginia, 23219, United States
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CABA, 1414, Argentina
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Ciudad de Buenos Aires, C1280AEB, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, 2000, Argentina
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Rosario, 2123, Argentina
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Anderlecht, 1070, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Itajaí, 88301-220, Brazil
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Jaú, 17210-070, Brazil
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Porto Alegre, 90035903, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Rio de Janeiro, 20560-120, Brazil
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São Paulo, 01236-030, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 1323001, Brazil
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North York, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Baoding, 071000, China
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Beijing, 100044, China
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Beijing, 100071, China
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Beijing, 100210, China
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Bengbu, 233004, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Guangzhou, 510060, China
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Hangzhou, 310003, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Jinan, 250001, China
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Jinan, 250117, China
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Linyi, 276000, China
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Nanchang, 330006, China
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Nanchang, 330009, China
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Shanghai, 200000, China
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Tianjin, 300060, China
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Xiamen, 361003, China
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Bezannes, 51430, France
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Bordeaux, 33030, France
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Lille, 59000, France
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Lyon, 69008, France
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Montpellier, 34070, France
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Plérin, 22190, France
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Toulouse, 31059, France
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Villejuif, 94800, France
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Heidelberg, 69120, Germany
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Homburg, 66421, Germany
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Leipzig, 4103, Germany
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München, 80637, Germany
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Ravensburg, 88212, Germany
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5000, Hungary
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Gurgaon, 122001, India
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Howrah, 711103, India
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Hyderabad, 500084, India
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Jaipur, 302022, India
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Kolkata, 700160, India
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Nashik, 422009, India
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Surat, 395002, India
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Visakhapatnam, 530017, India
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Bologna, 40138, Italy
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Candiolo, 10060, Italy
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Florence, 50139, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Prato, 59100, Italy
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Roma, 00168, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Fukushima, 960-1295, Japan
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Hiroshima, 730-8518, Japan
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Isehara-shi, 259-1193, Japan
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Kagoshima, 892-0833, Japan
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Kashiwa, 227-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Nishinomiya-shi, 663-8501, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sapporo, 003-0804, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1081 HV, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Venlo, 5912 BL, Netherlands
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Bialystok, 15-027, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Konin, 62-500, Poland
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Koszalin, 75-581, Poland
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Lodz, 90-302, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-781, Poland
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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George, 6529, South Africa
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Johannesburg, 2013, South Africa
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Johannesburg, 2196, South Africa
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Port Elizabeth, 6045, South Africa
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Pretoria, 0081, South Africa
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Goyang-si, 10408, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 6273, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08028, Spain
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Barcelona, 8036, Spain
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Bilbao (Vizcaya), 48013, Spain
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Huelva, 21005, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10050, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Blackpool, FY3 8NR, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Publications (2)
Bardia A, Jhaveri K, Im SA, Pernas S, De Laurentiis M, Wang S, Martinez Janez N, Borges G, Cescon DW, Hattori M, Lu YS, Hamilton E, Zhang Q, Tsurutani J, Kalinsky K, Rubini Liedke PE, Xu L, Fairhurst RM, Khan S, Denduluri N, Rugo HS, Xu B, Pistilli B; TROPION-Breast01 Investigators. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01. J Clin Oncol. 2025 Jan 20;43(3):285-296. doi: 10.1200/JCO.24.00920. Epub 2024 Sep 12.
PMID: 39265124DERIVEDBardia A, Jhaveri K, Kalinsky K, Pernas S, Tsurutani J, Xu B, Hamilton E, Im SA, Nowecki Z, Sohn J, Laurentiis M, Janez NM, Adamo B, Lee KS, Jung KH, Rubovszky G, Tseng LM, Lu YS, Yuan Y, Maxwell MJ, Haddad V, Khan SS, Rugo HS, Pistilli B. TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2- breast cancer. Future Oncol. 2024 Mar;20(8):423-436. doi: 10.2217/fon-2023-0188. Epub 2023 Jun 30.
PMID: 37387213DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 3, 2021
Study Start
October 18, 2021
Primary Completion
July 24, 2024
Study Completion (Estimated)
July 31, 2026
Last Updated
May 5, 2026
Results First Posted
February 4, 2026
Record last verified: 2026-05
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 de-identified 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