AzTrials
AzTrials

Breast CancerPhase 3NCT05374512

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

A Phase 3 study testing Dato-DXd, Paclitaxel and Nab-paclitaxel in people with Breast Cancer, run by AstraZeneca at 228 sites in 23 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

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. 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, Paclitaxel and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
644 participants
Where
228 sitesin 23 countries
Study dates
16 May 2022to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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
  • Histologically or cytologically documented locally recurrent inoperable TNBC, which cannot be treated with curative intent, or metastatic TNBC. TNBC is defined as:
  • Negative for ER with < 1% of tumour cells positive for ER on IHC.
  • Negative for progesterone receptor with < 1% of tumour cells positive for progesterone receptor on IHC.
  • Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline
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  • No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
  • Not a candidate for PD-1/PD-L1 inhibitor therapy, defined as:
  • Participants whose tumours are PD-L1-negative, or
  • Participants whose tumours are PD-L1-positive and have:
  • relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer,
  • comorbidities precluding PD-1/PD-L1 inhibitor therapy, or
  • no regulatory access to pembrolizumab [participant's country does not have regulatory approval at the time of screening]).
  • At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), and is suitable for accurate repeated measurements.
  • ECOG PS 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  • Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin), based on DFI and prior taxane exposure, per investigator assessment.
  • 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).
  • Corticosteroid therapy for central nervous system metastatic disease: > 3 days.
  • Anti cancer therapy including hormonal therapy: ≥ 3 weeks (for small molecule targeted agents: ≥ 2 weeks or 5 half-lives, whichever is longer).
  • Nitrosoureas or mitomycin C: ≥ 6 weeks.
  • Antibody-based anti cancer 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), retinoid therapy: ≥ 2 weeks or 5 times the terminal elimination half-life of the agent, whichever is longer.
  • Chloroquine/hydroxychloroquine: > 14 days.
  • Written confirmation of tumour sample needs to be available prior to enrolment and tumour samples should be available prior to randomisation. All participants must have a FFPE metastatic (excluding bone) or locally recurrent inoperable tumour sample (block preferred, or a minimum of 20 freshly cut slides) available, collected ≤ 3 months prior to screening. If neither an adequate FFPE block nor the minimum of 20 slides are available from the most recent biopsy, or if a biopsy is not feasible for safety reasons, and this is clearly documented, an archival tumour specimen obtained before the diagnosis of locally recurrent inoperable or metastatic breast cancer may be submitted, pending approval by the Global Study Team.
  • Participants with a history of previously treated neoplastic spinal cord compression or asymptomatic, stable brain metastases, who require no treatment with corticosteroids or anticonvulsants may be included in the study, if they are no longer symptomatic and have recovered from acute toxic effects of radiotherapy. A minimum of 2 weeks must have elapsed between the end of radiotherapy and Cycle 1 Day 1. A minimum of 3 days must have elapsed between the end of corticosteroid therapy for central nervous system metastatic disease and Cycle 1 Day 1.
  • Adequate organ and bone marrow function within 7 days before randomisation as follows:
  • Haemoglobin ≥ 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
  • Absolute neutrophil count ≥ 1.5 × 10^9/L (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment).
  • Platelet count ≥ 100 × 10^9/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
  • Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) or < 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia).
  • Except in the setting of HBV, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for AST/ALT (< 5 × ULN in participants with liver metastases). See Exclusion Criterion 5 for requirements in the setting of HBV.
  • Calculated CrCL ≥ 30 mL/minute as determined by Cockcroft Gault
  • Minimum life expectancy of 12 weeks.
  • Sex
  • Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Reproduction
  • Negative pregnancy test (serum) for women of childbearing potential.
  • Female participants must be at least 1 year post-menopausal, surgically sterile, or using at least 1 highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) Women of childbearing potential who are sexually active with a non sterilised male partner must agree to use at least 1 highly effective method of birth control. They should have been stable on their chosen method of birth control for a minimum of 3 months before Cycle 1 Day 1 and continue for at least 7 months after the last dose. Female participants must refrain from egg cell donation or retrieval for their own use, and breastfeeding from enrolment throughout the study and for at least 7 months after the last dose of study drug. Any non sterilised male partner of a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.
  • Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or use an acceptable method of contraception from the time of screening throughout the total duration of the study and the drug washout period (at least 6 months after the last dose of study intervention), in addition to the female partner using a highly effective contraceptive method, to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Preservation of sperm should be considered prior to randomisation. 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. Periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
  • Informed Consent
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • 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
  • As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, uncontrolled hypertension, history of allogeneic organ transplant, and active bleeding diseases, ongoing or active infection, or significant cardiac or psychological conditions), and/or substance abuse which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise 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 (per investigator assessment). Exceptions include adequately resected non-melanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma of the skin) and curatively treated in situ disease.
  • Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss).
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or nails are eligible).
  • Known active or uncontrolled hepatitis B or C virus infection.
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  • Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, cluster of differentiation (CD)4+ count > 350 cells/mm3, no history of an acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications.
  • Uncontrolled or significant cardiac disease including:
  • Myocardial infarction or uncontrolled/unstable angina within 6 months prior to Cycle 1 Day 1
  • Congestive heart failure (New York Heart Association Class II to IV), or
  • Uncontrolled or significant cardiac arrhythmia, or
  • Uncontrolled hypertension (resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
  • Resting ECG with clinically abnormal findings.
  • Uncontrolled hypercalcaemia: > 1.5 mmol/L (> 6 mg/dL) ionised calcium, or serum calcium (uncorrected for albumin) > 3 mmol/L (> 12 mg/dL), or corrected serum calcium > ULN, or clinically significant (symptomatic) hypercalcaemia.
  • History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has severe pulmonary function compromise.
  • Leptomeningeal carcinomatosis.
  • Clinically significant corneal disease.
  • Known active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
  • Prior/Concomitant Therapy
  • Prior exposure to:
  • Any treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I
  • TROP2-targeted therapy
  • Prior treatment with same ICC agent
  • Chloroquine/hydroxychloroquine without an adequate treatment washout period of > 14 days prior to randomisation.
  • Any concurrent anti cancer treatment.
  • Concurrent use of systemic hormone replacement therapy (HRT; eg, oestrogen and progesterone). However, concurrent use of hormones for other non-cancer-related conditions (eg, insulin for diabetes or levothyroxine for hypothyroidism) 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.
  • Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intra articular steroid injections are permitted in this study).
  • Prior/Concurrent Clinical Study Experience
  • Previous randomisation 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 dose of study intervention (unless the safety profile is known prior to randomisation), randomisation into a prior T-DXd or Dato DXd study regardless of treatment assignment, or concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study.
  • Participants with a known history of severe hypersensitivity reactions to either the drug or any excipients (including but not limited to polysorbate 80) of Dato-DXd or ICC.
  • 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.
  • Currently pregnant (confirmed with positive pregnancy test) or breast feeding or planning to become pregnant.

Trial locations and contacts

228 sites in 23 countries.

228 sites in 23 countries

China29 sites

  • Research Site

    Beijing, 100021

  • Research Site

    Beijing, 100039

  • Research Site

    Beijing, 100044

  • Research Site

    Bengbu, 233004

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610000

  • Research Site

    Chongqing, 400016

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510100

  • Research Site

    Hangzhou, 310003

  • Research Site

    Hangzhou, 310009

  • Research Site

    Hangzhou, 310022

  • Research Site

    Hefei, 230031

  • Research Site

    Hefei, 230601

  • Research Site

    Jinan, 250001

  • Research Site

    Jinan, 2501117

  • Research Site

    Nanchang, 330009

  • Research Site

    Nanjing, 210036

  • Research Site

    Shanghai, 200025

  • Research Site

    Shanghai, 201318

  • Research Site

    Shenyang, 110042

  • Research Site

    Shenzhen, 518020

  • Research Site

    Tianjin, 300000

  • Research Site

    Xi'an, 710004

  • Research Site

    Xi'an, 710100

  • Research Site

    Zhengzhou, 450008

  • Research Site

    Zhengzhou, 450052

Other trials in China

United States27 sites

  • Research Site

    Albuquerque, New Mexico, 87109

  • Research Site

    Atlanta, Georgia, 30322

  • Research Site

    Charlotte, North Carolina, 28204

  • Research Site

    Charlottesville, Virginia, 22908

  • Research Site

    Detroit, Michigan, 48201

  • Research Site

    Duarte, California, 91010

  • Research Site

    Fort Worth, Texas, 76104

  • Research Site

    Grand Junction, Colorado, 81501

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Kingwood, Texas, 77339

  • Research Site

    Longmont, Colorado, 80504

  • Research Site

    Los Angeles, California, 90017

  • Research Site

    Louisville, Kentucky, 40207

  • Research Site

    Madison, Wisconsin, 53792

  • Research Site

    Memphis, Tennessee, 38120

  • Research Site

    Miami, Florida, 33170

  • Research Site

    Miami, Florida, 33176

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    New Haven, Connecticut, 06510

  • Research Site

    New York, New York, 10065

  • Research Site

    Providence, Rhode Island, 02903

  • Research Site

    San Antonio, Texas, 78240

  • Research Site

    San Francisco, California, 94143

  • Research Site

    Sioux Falls, South Dakota, 57105

  • Research Site

    Spokane Valley, Washington, 99216

  • Research Site

    Washington D.C., District of Columbia, 20010

  • Research Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan19 sites

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Fukushima, 960-1295

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Isehara-shi, 259-1193

  • Research Site

    Kagoshima, 892-0833

  • Research Site

    Kashiwa, 277-8577

  • 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

    Nagoya, 466-8560

  • Research Site

    Niigata, 951-8566

  • Research Site

    Nishinomiya-shi, 663-8501

  • Research Site

    Sendai, 980-8574

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shinjuku-ku, 162-8655

  • Research Site

    Tsukuba, 305-8577

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Germany11 sites

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Bonn, 53111

  • Research Site

    Frankfurt am Main, 60431

  • Research Site

    Georgsmarienhütte, 49124

  • Research Site

    Hanover, 30625

  • Research Site

    Heilbronn, 74078

  • Research Site

    Koblenz Am Rhein, 56068

  • Research Site

    Langen, 63225

  • Research Site

    München, 81377

  • Research Site

    Münster, 48149

  • Research Site

    Wiesbaden, 65199

Other trials in Germany

Italy11 sites

  • Research Site

    Borgo San Lorenzo, 50032

  • Research Site

    Catanzaro, 88100

  • Research Site

    Genova, 16132

  • Research Site

    Livorno, 57126

  • Research Site

    Milan, 20132

  • Research Site

    Milan, 20141

  • Research Site

    Modena, 41124

  • Research Site

    Naples, 80131

  • Research Site

    Province of Macerata, 62100

  • Research Site

    Roma, 00137

  • Research Site

    Rozzano, 20089

Other trials in Italy

Spain11 sites

  • Research Site

    Barcelona, 08028

  • Research Site

    Barcelona, 8035

  • Research Site

    Granada, 18016

  • Research Site

    L'Hospitalet de Llobregat, 08908

  • Research Site

    Madrid, 28007

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28046

  • Research Site

    Majadahonda, 28222

  • Research Site

    Málaga, 29010

  • Research Site

    Santiago de Compostela, 15706

  • Research Site

    Seville, 41013

Other trials in Spain

Brazil10 sites

  • Research Site

    Brasília, 71681-603

  • Research Site

    Curitiba, 80440-220

  • Research Site

    Goiânia, 74000-000

  • Research Site

    Jaú, 17210-120

  • Research Site

    Porto Alegre, 90619-900

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Rio de Janeiro, 20560-120

  • Research Site

    São Paulo, 01246-000

  • Research Site

    São Paulo, 01321-001

  • Research Site

    São Paulo, 01409-001

Other trials in Brazil

France10 sites

  • Research Site

    Bordeaux, 33076

  • Research Site

    Dijon, 21079

  • Research Site

    Limoges, 87042

  • Research Site

    Lyon, 69373

  • Research Site

    Marseille, 13273

  • Research Site

    Montpellier, 34298

  • Research Site

    Paris, 75010

  • Research Site

    Rouen, 76021

  • Research Site

    Saint-Herblain, 44805

  • Research Site

    Tours, 37000

Other trials in France

United Kingdom9 sites

  • Research Site

    Bristol, BS2 8ED

  • Research Site

    Cardiff, CF14 2TL

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    London, EC1A 7BE

  • Research Site

    London, SE1 9RT

  • Research Site

    London, SW17 0QT

  • Research Site

    Northampton, NN1 5BD

  • Research Site

    Nottingham, NG5 1PB

  • Research Site

    Warwick, CV34 5BW

Other trials in United Kingdom

Argentina8 sites

  • Research Site

    Buenos Aires, 1058

  • Research Site

    CABA, 1414

  • Research Site

    CABA, 1426

  • Research Site

    CABA, C1113AAE

  • Research Site

    Ciudad Autónoma Buenos Aires, C1430EFA

  • Research Site

    Ciudad de Buenos Aires, 1426

  • Research Site

    Mar del Plata, B7600

  • Research Site

    Rosario, 2000

Other trials in Argentina

Canada8 sites

  • Research Site

    Barrie, Ontario, L4M 6M2

  • Research Site

    Calgary, Alberta, T2N 5G2

  • Research Site

    Greenfield Park, Quebec, J4V 2H1

  • Research Site

    Hamilton, Ontario, L8V 5C2

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Ottawa, Ontario, K1H 8L6

  • Research Site

    Québec, Quebec, G1S 4L8

  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

India8 sites

  • Research Site

    Bangalore, 560004

  • Research Site

    Jaipur, 302022

  • Research Site

    Kolkata, 700160

  • Research Site

    Nagpur, 440001

  • Research Site

    Nashik, 422009

  • Research Site

    New Delhi, 110085

  • Research Site

    Puducherry, 605006

  • Research Site

    Vadodara, 391760

Other trials in India

Philippines8 sites

  • Research Site

    Bacolod, 6100

  • Research Site

    Cebu, 6000

  • Research Site

    Cebu City, 6000

  • Research Site

    City of Muntinlupa, 1780

  • Research Site

    Iloilo City, 5000

  • Research Site

    Quezon City, 1101

  • Research Site

    Quezon City, 1112

  • Research Site

    San Juan City, 1500

Other trials in Philippines

Taiwan8 sites

  • Research Site

    Hsinchu, 300

  • Research Site

    Taichung, 40447

  • Research Site

    Taichung, 40705

  • Research Site

    Tainan, 70403

  • Research Site

    Tainan, 710

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 11217

  • Research Site

    Taoyuan, 00333

Other trials in Taiwan

South Korea7 sites

  • Research Site

    Busan, 602-739

  • Research Site

    Daegu, 41404

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06273

  • Research Site

    Seoul, 06351

Other trials in South Korea

Thailand7 sites

  • Research Site

    Bangkok, 10210

  • Research Site

    Bangkok, 10330

  • Research Site

    Bangkok, 10400

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Dusit, 10300

  • Research Site

    Hat Yai, 90110

  • Research Site

    Khon Kaen, 40002

Other trials in Thailand

Turkey (Türkiye)7 sites

  • Research Site

    Ankara, 06340

  • Research Site

    Ankara, 06520

  • Research Site

    Diyarbakır, 21280

  • Research Site

    Istanbul, 34662

  • Research Site

    Izmir, 35575

  • Research Site

    Konya, 42080

  • Research Site

    Malatya, 44280

Other trials in Turkey (Türkiye)

Mexico6 sites

  • Research Site

    CD Mexico, 04980

  • Research Site

    Guadalajara, 44670

  • Research Site

    Guadalajara Jalisco, 44280

  • Research Site

    México, 14080

  • Research Site

    México, 6760

  • Research Site

    Mexico City, 0 3100

Other trials in Mexico

Poland6 sites

  • Research Site

    Bialystok, 15-027

  • Research Site

    Bydgoszcz, 85-796

  • Research Site

    Lodz, 93-338

  • Research Site

    Poznan, 60-192

  • Research Site

    Warsaw, 02-781

  • Research Site

    Wroclaw, 53-413

Other trials in Poland

Belgium5 sites

  • Research Site

    Anderlecht, 1070

  • Research Site

    Ghent, 9000

  • Research Site

    Namur, 5000

  • Research Site

    Sint-Niklaas, 9100

  • Research Site

    Wilrijk, 2610

Other trials in Belgium

Hungary5 sites

  • Research Site

    Budapest, 1062

  • Research Site

    Budapest, 1122

  • Research Site

    Miskolc, 3526

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Zalaegerszeg, 8900

Other trials in Hungary

South Africa5 sites

  • Research Site

    Cape Town, 7570

  • Research Site

    Johannesburg, 2196

  • Research Site

    Pretoria, 0002

  • Research Site

    Pretoria, 0081

  • Research Site

    Soweto, 2013

Other trials in South Africa

Singapore3 sites

  • Research Site

    Bukit Merah, 169610

  • Research Site

    Singapore, 119074

  • Research Site

    Singapore, 308433

Other trials in Singapore

About this study

Official title: A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Read the detailed description

The primary objectives of the study are to demonstrate superiority of Dato-DXd relative to ICC by assessment of PFS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and to demonstrate superiority of Dato-DXd relative to ICC by assessment of OS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Conditions
Breast Cancer
Keywords
Breast Cancer;, PD-1/PD-L1 Therapy;, Dato-DXd; DS1062a;, TROP2;, Triple-negative;, Metastatic; Inoperable;, Datopotamab deruxtecan;, 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.

  • PaclitaxelDrug

    IV Infusion. Active comparator

  • Nab-paclitaxelDrug

    IV infusion. Active comparator

  • CarboplatinDrug

    IV infusion. Active comparator

  • CapecitabineDrug

    Tablet. Oral route of administration. Active comparator

  • Eribulin mesylateDrug

    IV infusion. Active comparator

Study groups in NCT05374512
Study groupRoleWhat they receive
Dato-DXdExperimentalArm 1: Dato-DXd
Receives: Drug: Dato-DXd
Investigator's Choice of Chemotherapy (ICC)Active comparatorArm 2: If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI > 12 months, paclitaxel or nab-paclitaxel If prior taxane and DFI ≤ 12 months: capecitabine, carboplatin, or eribulin.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Capecitabine; Drug: Eribulin mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.

    The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits.

    The measure of interest is the hazard ratio [HR] of PFS.

    Measured: From randomization until progression as assessed by BICR or death due to any cause (anticipated to be up to 26 months)

  2. Overall Survival (OS)

    OS is defined as the time from randomisation until the date of death due to any cause.

    The analysis will include all randomised participants, by treatment group as randomised. The measure of interest is the hazard ratio [HR] of OS.

    Measured: From randomisation until the date of death due to any cause (approximately 42 months)

Secondary outcomes (14)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1.

    The analysis will include all randomised participants, by treatment group as randomised.

    Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent anti-cancer therapy, and then respond will not be included as responders in the ORR.

    The measure of interest is the odds ratio of the ORR.

    Measured: From randomisation up until progression (anticipated to be up to 26 months)

  2. Duration of Response (DoR)

    DoR 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/investigator assessment or death due to any cause.

    The analysis will include all randomised participants as randomised who have a confirmed response, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.

    The measure of interest is the median of DoR,

    Measured: From the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 26 months)

  3. Progression-Free Survival (PFS) by Investigator assessment

    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.

    The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.

    The measure of interest is the hazard ratio [HR] of PFS.

    Measured: From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months)

  4. Disease Control Rate (DCR)

    DCR at 12 weeks is defined as the percentage of participants who have a confirmed CR or PR or who have SD, per RECIST 1.1, as assessed by BICR/investigator assessment and derived from the raw tumour data for at least 11 weeks after randomisation.

    The analysis will include all randomised participants by treatment group as randomised.

    Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of DCR, regardless of whether the participant withdraws from therapy. Participants who receive a subsequent anticancer therapy prior to Week 11 will not be considered to have disease control in the analysis.

    The measure of interest is the odds ratio of the DCR.

    Measured: At least 11 weeks after randomization to 23 months

  5. Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC

    TTD in pain as measured by the pain scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in pain.

    Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)

  6. Time to deterioration (TTD) in physical functioning in participants treated with Dato DXd compared with ICC

    TTD in physical functioning as measured by the physical functioning scale from EORTC IL146.

    TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in physical functioning.

    Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)

  7. Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato DXd compared to ICC

    • TTD in breast symptoms as measured by the breast symptoms scale from EORTC IL116
    • TTD in arm symptoms as measured by the arm symptoms scale from EORTC IL116 TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in breast symptoms/arm symptoms.

    Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)

  8. Time to deterioration (TTD) in GHS/QoL in participants treated with Dato DXd compared with ICC

    TTD in GHS/QoL as measured by the GHS/QoL scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.

    The measure of interest is the hazard ratio [HR] of TTD in GHS/QoL.

    Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)

  9. Time to First Subsequent Therapy (TFST)

    TFST is defined as the time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.

    The analysis will include all randomised participants as randomised, regardless of progression status.

    The measure of interest is the hazard ratio [HR] of TFST.

    Measured: From randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 26 months)

  10. Time to Second Subsequent Therapy (TSST)

    TSST is defined as the time from randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    The analysis will include all randomised participants as randomised, regardless of progression status on study treatment or first subsequent treatment.

    The measure of interest is the hazard ratio [HR] of TSST.

    Measured: From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 26 months)

  11. Progression Free Survival 2 (PFS2)

    PFS2 will be defined as the time from randomisation 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.

    The analysis will include all randomised participants as randomised regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits.

    The measure of interest is the hazard ratio [HR] of PFS2.

    Measured: From randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 26 months)

  12. Pharmacokinetics of Dato-DXd

    Concentration of Dato DXd, total anti-TROP2 antibody, and MAAA-1181a in plasma.

    Measured: From first dose to end of treatment (anticipated to be up to 26 months)

  13. Immunogenicity of Dato-DXd

    Presence of ADAs for Dato-DXd (confirmatory results: positive or negative, titres).

    Measured: From first dose to end of treatment safety follow-up (anticipated to be up to 26 months)

  14. Safety of Dato-DXd

    Safety will be evaluated in terms of AEs (graded by CTCAE version 5.0)

    Measured: From first dose to end of treatment safety follow-up (anticipated to be up to 26 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start16 May 2022
  3. Primary completion25 Aug 2025
  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
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Masking
None (open label)
Enrolment
644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374512
Sponsor's protocol ID
D926PC00001
Other IDs
2023-509260-25, 2021-005223-21, 2023
Status last verified
May 2026
First submitted
19 Apr 2022
Last updated
15 May 2026
Results posted
No
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 Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Dent RA, Cescon DW, Bachelot T, Jung KH, Shao ZM, Saji S, Traina TA, Vukovic P, Mapiye D, Maxwell MJ, Schmid P, Cortes J. TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer. Future Oncol. 2023 Nov;19(35):2349-2359. doi: 10.2217/fon-2023-0228. Epub 2023 Aug 1.

    PubMed 37526149

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dato-DXd, Paclitaxel and Nab-paclitaxel in people with Breast Cancer, run by AstraZeneca at 228 sites in 23 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 44 inclusion and 39 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in China, United States, Japan, Germany, Italy and 18 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?

This study is still under way. Results are not available in the source record yet.

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 (PFS) (time frame: From randomization until progression as assessed by BICR or death due to any cause (anticipated to be up to 26 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 NCT05374512, which also lists 1 linked publication.

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 15 May 2026.

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