Breast CancerPhase 3NCT05104866
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)
A Phase 3 study testing Dato-DXd, Capecitabine and Gemcitabine in people with Breast Cancer, run by AstraZeneca at 167 sites in 20 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dato-DXd, Capecitabine and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 167 sitesin 20 countries
- Study dates
- 18 Oct 2021to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Has had an adequate treatment washout period before Cycle 1 Day 1, defined as:
- Major surgery: ≥ 3 weeks.
- Radiation therapy including palliative radiation to chest: ≥ 4 weeks (palliative radiation therapy to other areas ≥ 2 weeks).
- Anticancer therapy including hormonal therapy: ≥ 3 weeks (for small molecule targeted agents: ≥ 2 weeks or 5 half-lives, whichever is longer).
- Antibody-based anticancer therapy: ≥ 4 weeks with the exception of receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors (eg, denosumab for the treatment of bone metastases).
- Immunotherapy (non-antibody-based therapy): ≥ 2 weeks or 5 times the terminal elimination T½ of the agent, whichever is longer.
- Chloroquine/hydroxychloroquine: > 14 days.
- Have available a FFPE tumor sample (block preferred, or a minimum of 20 freshly cut slides), at the time of screening. Note: Sample collection in China will comply with local regulatory approval.
- Minimum life expectancy of 12 weeks at screening.
- Sex
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; (oral estrogens are not permitted).
- Reproduction
- Negative pregnancy test (serum) for women of childbearing potential
- Female participants must be post-menopausal for at least 1 year, surgically sterile, or using one highly effective form of birth control. Female participants must refrain from egg cell donation and breastfeeding while on study and for at least 7 months after the last dose of study intervention. Non-sterilized male partners of a woman of childbearing potential must use a male condom plus spermicide throughout this period.
- Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and drug washout period is an acceptable practice if this is the preferred usual lifestyle of the participant; however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female partners of male participants are allowed to use HRT for contraception.
- Informed Consent
- Capable of giving signed informed consent.
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample for optional genetic research that supports Genomic Initiative.
Who cannot join
- 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.
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- 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.
- Clinically significant corneal disease.
- Known active tuberculosis infection
- Prior/Concomitant Therapy
- Any of the following prior anticancer therapies:
- Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I
- TROP2-targeted therapy
- Prior treatment with same ICC agent
- Any concurrent anticancer treatment, with the exception of bisphosphonates, denosumab, for the treatment of bone metastases.
- Concurrent use of systemic hormonal replacement therapy (eg, estrogen). However, concurrent use of hormones for non-cancer related conditions (eg, insulin for diabetes) is acceptable.
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of study treatment.
- Prior/Concurrent Clinical Study Experience
- Previous treatment in the present study.
- Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dosing, randomization into a prior Dato-DXd or T-DXd (trastuzumab deruxtecan) study regardless of treatment assignment, or concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.
- Participants with a known hypersensitivity to Dato-DXd, or any of the excipients of the product (including, but not limited to, polysorbate 80).
- Known history of severe hypersensitivity reactions to other monoclonal antibodies.
- Other Exclusions
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- For women only, currently pregnant (confirmed with positive pregnancy test) or breastfeeding, or who are planning to become pregnant.
Trial locations and contacts
167 sites in 20 countries.
167 sites in 20 countries
China21 sites
Research Site
Baoding, 071000
Research Site
Beijing, 100044
Research Site
Beijing, 100071
Research Site
Beijing, 100210
Research Site
Bengbu, 233004
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610000
Research Site
Guangzhou, 510060
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310020
Research Site
Hangzhou, 310022
Research Site
Harbin, 150049
Research Site
Jinan, 250001
Research Site
Jinan, 250117
Research Site
Linyi, 276000
Research Site
Nanchang, 330006
Research Site
Nanchang, 330009
Research Site
Shanghai, 200000
Research Site
Tianjin, 300060
Research Site
Xiamen, 361003
Japan19 sites
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 811-1395
Research Site
Fukushima, 960-1295
Research Site
Hiroshima, 730-8518
Research Site
Isehara-shi, 259-1193
Research Site
Kagoshima, 892-0833
Research Site
Kashiwa, 227-8577
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kōtoku, 135-8550
Research Site
Kyoto, 606-8507
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 464-8681
Research Site
Nishinomiya-shi, 663-8501
Research Site
Osaka, 541-8567
Research Site
Osakasayama-shi, 589-8511
Research Site
Sapporo, 003-0804
Research Site
Shinagawa-ku, 142-8666
Research Site
Shinjuku-ku, 162-8655
Research Site
Yokohama, 241-8515
United States14 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Cleveland, Ohio, 44119
Research Site
Duarte, California, 91010
Research Site
Grand Rapids, Michigan, 49503
Research Site
Jacksonville, Florida, 32207
Research Site
Los Angeles, California, 90095
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10065
Research Site
Palo Alto, California, 94305-5826
Research Site
Portland, Oregon, 97239
Research Site
Richmond, Virginia, 23219
Research Site
San Francisco, California, 94143
Spain11 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 08028
Research Site
Barcelona, 8036
Research Site
Bilbao (Vizcaya), 48013
Research Site
Huelva, 21005
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28034
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Madrid, 28040
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Málaga, 29010
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Seville, 41013
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Valencia, 46010
United Kingdom11 sites
Research Site
Blackpool, FY3 8NR
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Bristol, BS2 8ED
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Cardiff, CF14 2TL
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Colchester, CO4 5JL
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Edinburgh, EH4 2XU
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London, EC1A 7BE
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London, SW3 6JJ
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Manchester, M20 4BX
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Nottingham, NG5 1PB
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Sutton, SM2 5PT
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Truro, TR1 3LJ
Italy10 sites
Research Site
Bologna, 40138
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Candiolo, 10060
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Florence, 50139
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Meldola, 47014
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Milan, 20132
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Milan, 20141
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Naples, 80131
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Padova, 35128
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Prato, 59100
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Roma, 00168
Brazil9 sites
Research Site
Itajaí, 88301-220
Research Site
Jaú, 17210-070
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Porto Alegre, 90035903
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Ribeirão Preto, 14051-140
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Rio de Janeiro, 20560-120
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São Paulo, 01236-030
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São Paulo, 01246-000
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São Paulo, 01509-900
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São Paulo, 1323001
France8 sites
Research Site
Bezannes, 51430
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Bordeaux, 33030
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Lille, 59000
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Lyon, 69008
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Montpellier, 34070
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Plérin, 22190
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Toulouse, 31059
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Villejuif, 94800
India8 sites
Research Site
Gūrgaon, 122001
Research Site
Howrah, 711103
Research Site
Hyderabad, 500084
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Jaipur, 302022
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Kolkata, 700160
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Nashik, 422009
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Surat, 395002
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Visakhapatnam, 530017
Poland8 sites
Research Site
Bialystok, 15-027
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Gdansk, 80-952
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Gdynia, 81-519
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Konin, 62-500
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Koszalin, 75-581
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Lodz, 90-302
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Tomaszów Mazowiecki, 97-200
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Warsaw, 02-781
Taiwan8 sites
Research Site
Kaohsiung City, 82445
Research Site
Kaohsiung City, 833
Research Site
Taichung, 40447
Research Site
Tainan, 70403
Research Site
Taipei, 10050
Research Site
Taipei, 10449
Research Site
Taipei, 11217
Research Site
Taoyuan, 333
South Korea7 sites
Research Site
Goyang-si, 10408
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
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Seoul, 06351
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Seoul, 6273
Argentina6 sites
Research Site
CABA, 1414
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Ciudad de Buenos Aires, C1280AEB
Research Site
La Plata, 1900
Research Site
Mar del Plata, 7600
Research Site
Rosario, 2000
Research Site
Rosario, 2123
Canada5 sites
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Montreal, Quebec, H4A 3J1
Research Site
North York, Ontario, M2K 1E1
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Québec, Quebec, G1S 4L8
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Toronto, Ontario, M5G 2M9
Germany5 sites
Research Site
Heidelberg, 69120
Research Site
Homburg, 66421
Research Site
Leipzig, 4103
Research Site
München, 80637
Research Site
Ravensburg, 88212
South Africa5 sites
Research Site
George, 6529
Research Site
Johannesburg, 2013
Research Site
Johannesburg, 2196
Research Site
Port Elizabeth, 6045
Research Site
Pretoria, 0081
Hungary4 sites
Research Site
Budapest, 1062
Research Site
Budapest, 1122
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Szekszárd, 7100
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Szolnok, 5000
Belgium3 sites
Research Site
Anderlecht, 1070
Research Site
Leuven, 3000
Research Site
Liège, 4000
Netherlands3 sites
Research Site
Amsterdam, 1081 HV
Research Site
Rotterdam, 3083 AN
Research Site
Venlo, 5912 BL
About this study
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.
Read the detailed description
The primary objective of this study will assess the safety and efficacy of datopotamab deruxtecan (Dato-DXd) 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.
The study will be stratified based on number of previous lines of chemotherapy (1 vs. 2), prior use of CDK4/6 inhibitors (Yes vs. no) and geographic region of participant (US/Canada/Europe vs. rest of world).
This study aims to see if datopotamab deruxtecan allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
- Conditions
- Breast Cancer
- Being tested
- Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine
- Keywords
- Breast Cancer, HR positive, Hormone Receptor positive, ER positive, PR positive, HER2 negative, Inoperable, Metastatic, Datopotamab Deruxtecan, Dato-DXd, DS1062, DS1062a, Capecitabine, Eribulin, Gemcitabine, Vinorelbine, TROP2, Antibody Drug Conjugate, ADC
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dato-DXdDrug
Also called Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Experimental drug. Provided in 100mg vials. IV infusion.
CapecitabineDrug
Tablet. Oral route of administration. Active comparator
GemcitabineDrug
IV Infusion. Active comparator
EribulinDrug
Also called Eribulin Mesylate
IV Infusion. Active comparator
VinorelbineDrug
IV Infusion. Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Dato-DXd | Experimental | Arm 1: Dato-DXd Receives: Drug: Dato-DXd |
| Investigators Choice of Chemotherapy (ICC) | Active comparator | Arm 2: ICC
Capecitabine
Gemcitabine
Eribulin mesylate
Vinorelbine Receives: Drug: Capecitabine; Drug: Gemcitabine; Drug: Eribulin; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.
Measured: 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
Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR assessment or death due to any cause.
Measured: 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
Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by Investigator assessment or death due to any cause.
Measured: 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
PFS by Investigator assessment will be defined as the time from the date of randomization until the date of PD per RECIST 1.1 (by Investigator assessment) or death (by any cause in the absence of progression), (ie, date of event or censoring - date of randomization + 1).
Measured: 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)
DCR is defined as the percentage of participants who have a confirmed CR or PR up to data cut-off date or who have SD for at least 11 weeks after randomization, per RECIST 1.1, as assessed BICR/per investigator assessment and derived from the raw tumor data.
Measured: 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.
Time to First Subsequent Therapy (TFST)
Time to first subsequent therapy is defined as the time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
Measured: From randomization to start of first subsequent anti-cancer therapy. Assessments occur at every visit after study treatment has been discontinued. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Time to Second Subsequent Therapy (TSST)
Time to second subsequent therapy is defined as the time from randomization to until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
Measured: From randomization to start of second subsequent anti-cancer therapy. Assessments occur at every visit after study treatment has been discontinued. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Time From Randomization to Second Progression or Death (PFS2)
Time to second progression of death will be defined as the time from the randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice.
Measured: From date of randomization to second progression or death. PFS2 assessments occur every 3 months after disease progression. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months
Clinical Outcome Assessment- TTD in Pain
Time to deterioration in pain as measured by the pain scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 increase in score relative to baseline score
Measured: From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Clinical Outcome Assessment- TTD in Physical Functioning
Time to deterioration in physical functioning as measured by the physical functioning scale from EORTC QLQ-C30. Deterioration is defined as a 13.3 decrease in score relative to baseline score.
Measured: From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Clinical Outcome Assessment- TTD in GHS
Time to deterioration in global health status/QoL as measured by the global health status/QoL scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 decrease in score relative to baseline score.
Measured: From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start18 Oct 2021
- Primary completion24 Jul 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104866
- Sponsor's protocol ID
- D9268C00001
- Other IDs
- 2023-509631-37-00, 2020-005620-12, 2023
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2021
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39265124Bardia 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.
PubMed 37387213