AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
Show all 33Show fewer
  • 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.
Show all 35Show fewer
  • 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

Other trials in China

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

Other trials in Japan

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

Other trials in United States

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

  • Research Site

    Madrid, 28040

  • Research Site

    Málaga, 29010

  • Research Site

    Seville, 41013

  • Research Site

    Valencia, 46010

Other trials in Spain

United Kingdom11 sites

  • Research Site

    Blackpool, FY3 8NR

  • Research Site

    Bristol, BS2 8ED

  • Research Site

    Cardiff, CF14 2TL

  • Research Site

    Colchester, CO4 5JL

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    London, EC1A 7BE

  • Research Site

    London, SW3 6JJ

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Nottingham, NG5 1PB

  • Research Site

    Sutton, SM2 5PT

  • Research Site

    Truro, TR1 3LJ

Other trials in United Kingdom

Italy10 sites

  • Research Site

    Bologna, 40138

  • Research Site

    Candiolo, 10060

  • Research Site

    Florence, 50139

  • Research Site

    Meldola, 47014

  • Research Site

    Milan, 20132

  • Research Site

    Milan, 20141

  • Research Site

    Naples, 80131

  • Research Site

    Padova, 35128

  • Research Site

    Prato, 59100

  • Research Site

    Roma, 00168

Other trials in Italy

Brazil9 sites

  • Research Site

    Itajaí, 88301-220

  • Research Site

    Jaú, 17210-070

  • Research Site

    Porto Alegre, 90035903

  • Research Site

    Ribeirão Preto, 14051-140

  • Research Site

    Rio de Janeiro, 20560-120

  • Research Site

    São Paulo, 01236-030

  • Research Site

    São Paulo, 01246-000

  • Research Site

    São Paulo, 01509-900

  • Research Site

    São Paulo, 1323001

Other trials in Brazil

France8 sites

  • Research Site

    Bezannes, 51430

  • Research Site

    Bordeaux, 33030

  • Research Site

    Lille, 59000

  • Research Site

    Lyon, 69008

  • Research Site

    Montpellier, 34070

  • Research Site

    Plérin, 22190

  • Research Site

    Toulouse, 31059

  • Research Site

    Villejuif, 94800

Other trials in France

India8 sites

  • Research Site

    Gūrgaon, 122001

  • Research Site

    Howrah, 711103

  • Research Site

    Hyderabad, 500084

  • Research Site

    Jaipur, 302022

  • Research Site

    Kolkata, 700160

  • Research Site

    Nashik, 422009

  • Research Site

    Surat, 395002

  • Research Site

    Visakhapatnam, 530017

Other trials in India

Poland8 sites

  • Research Site

    Bialystok, 15-027

  • Research Site

    Gdansk, 80-952

  • Research Site

    Gdynia, 81-519

  • Research Site

    Konin, 62-500

  • Research Site

    Koszalin, 75-581

  • Research Site

    Lodz, 90-302

  • Research Site

    Tomaszów Mazowiecki, 97-200

  • Research Site

    Warsaw, 02-781

Other trials in Poland

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

Other trials in Taiwan

South Korea7 sites

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 02841

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 6273

Other trials in South Korea

Argentina6 sites

  • Research Site

    CABA, 1414

  • Research Site

    Ciudad de Buenos Aires, C1280AEB

  • Research Site

    La Plata, 1900

  • Research Site

    Mar del Plata, 7600

  • Research Site

    Rosario, 2000

  • Research Site

    Rosario, 2123

Other trials in Argentina

Canada5 sites

  • Research Site

    Montreal, Quebec, H3T 1E2

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    North York, Ontario, M2K 1E1

  • Research Site

    Québec, Quebec, G1S 4L8

  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany5 sites

  • Research Site

    Heidelberg, 69120

  • Research Site

    Homburg, 66421

  • Research Site

    Leipzig, 4103

  • Research Site

    München, 80637

  • Research Site

    Ravensburg, 88212

Other trials in Germany

South Africa5 sites

  • Research Site

    George, 6529

  • Research Site

    Johannesburg, 2013

  • Research Site

    Johannesburg, 2196

  • Research Site

    Port Elizabeth, 6045

  • Research Site

    Pretoria, 0081

Other trials in South Africa

Hungary4 sites

  • Research Site

    Budapest, 1062

  • Research Site

    Budapest, 1122

  • Research Site

    Szekszárd, 7100

  • Research Site

    Szolnok, 5000

Other trials in Hungary

Belgium3 sites

  • Research Site

    Anderlecht, 1070

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, 4000

Other trials in Belgium

Netherlands3 sites

  • Research Site

    Amsterdam, 1081 HV

  • Research Site

    Rotterdam, 3083 AN

  • Research Site

    Venlo, 5912 BL

Other trials in Netherlands

Russia2 sites

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 143423

Other trials in Russia

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 groups in NCT05104866
Study groupRoleWhat they receive
Dato-DXdExperimentalArm 1: Dato-DXd
Receives: Drug: Dato-DXd
Investigators Choice of Chemotherapy (ICC)Active comparatorArm 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.

  1. 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

  2. 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)

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  1. First posted3 Nov 2021
  2. Study start18 Oct 2021
  3. Primary completion24 Jul 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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
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 39265124

  • Bardia 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dato-DXd, Capecitabine and Gemcitabine in people with Breast Cancer, run by AstraZeneca at 167 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in China, Japan, United States, Spain, United Kingdom and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104866, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in