A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Last updated: March 7, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Paclitaxel

Epirubicin

Dato-DXd

Clinical Study ID

NCT06112379
D926QC00001
2023-505928-59-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥ 18 years, at the time of signing the ICF.

  • Histologically confirmed Stage II or III unilateral or bilateral primary invasiveTNBC or hormone receptor-low/HER2-negative breast cancer

  • ECOG PS of 0 or 1

  • Provision of acceptable tumor sample

  • Adequate bone marrow reserve and organ function

  • Contraceptive use by males or females should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studiesand aligned with protocol requirements.

Exclusion

Exclusion criteria:

  • History of any prior invasive breast malignancy

  • History of another primary malignancy except for malignancy treated with curativeintent with no known active disease within 5 years before randomization.

  • active or prior documented autoimmune or inflammatory disorders.

  • Evidence of distant disease.

  • Clinically significant corneal disease.

  • Has active or uncontrolled hepatitis B or C virus infection.

  • Known HIV infection that is not well controlled.

  • Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals;suspected infections; or inability to rule out infections.

  • Known to have active tuberculosis infection

  • Mean resting corrected QTcF interval > 470 ms obtained from ECG

  • Uncontrolled or significant cardiac disease.

  • History of non-infectious ILD/pneumonitis

  • Has severe pulmonary function compromise

  • Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy forTNBC or hormone receptor-low/HER2-negative breast cancer

  • For females only: is pregnant (confirmed with positive serum pregnancy test) orbreastfeeding, or planning to become pregnant.

  • Female participants should refrain from breastfeeding from enrolment throughout thestudy and for at least 7 months after last dose of study intervention, or asdictated by local PI for SoC if longer.

  • Concurrent use of systemic hormone replacement therapy or oral hormonalcontraception

Study Design

Total Participants: 1728
Treatment Group(s): 10
Primary Treatment: Paclitaxel
Phase: 3
Study Start date:
November 14, 2023
Estimated Completion Date:
August 28, 2030

Study Description

The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer, by central assessment of pCR and/or to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS

Connect with a study center

  • Research Site

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Research Site

    East Melbourne, 3002
    Australia

    Active - Recruiting

  • Research Site

    Heidelberg, 3084
    Australia

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    Herston, 4029
    Australia

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    Nedlands, 6009
    Australia

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    Waratah, 2298
    Australia

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    Feldkirch, 6807
    Austria

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    Graz, 8036
    Austria

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    Innsbruck, 6020
    Austria

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    Linz, 4010
    Austria

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    Salzburg, 5020
    Austria

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    Brasschaat, 2930
    Belgium

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    Charleroi, 6060
    Belgium

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    Gent, 9000
    Belgium

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    Leuven, 3000
    Belgium

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    Libramont-Chevigny, 6800
    Belgium

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    Wilrijk, 2610
    Belgium

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    Brasilia, 71681-603
    Brazil

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    Curitiba, 80440-220
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    Fortaleza, 60336-045
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    Londrina, 86015-520
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    Natal, 59075-740
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    Porto Alegre, 90035-903
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    Ribeirão Preto, 14051-140
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    Santo Andre, 09060-650
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    São Paulo, 01246-000
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    Taubaté, 12030-200
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    Vitória, 29043-260
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    Shumen, 9700
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    Sofia, 1431
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    Vratza, 3000
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    Abbotsford, British Columbia V2S0C2
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    Ulm, 89075
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    Kecskemét, 6000
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    Szekszárd, 7100
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    Tricase, 73039
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    Chuo-ku, 104-8560
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    Fukushima-shi, 960-1295
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    Gifu-shi, 501-1194
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    Hidaka-shi, 350-1298
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    Hirakata-shi, 573-1191
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    Hiroshima-shi, 734-8551
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    Isehara-shi, 259-1193
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    Kashiwa, 227-8577
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    Koto-ku, 135-8550
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    Kurume-shi, 830-0011
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    Kyoto-shi, 606-8507
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    Matsuyama-shi, 791-0280
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    Okayama, 700-8558
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    Osaka-shi, 541-8567
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    Tokyo, 104-0045
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    Seongnam, 13620
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    Seoul, 05505
    Korea, Republic of

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    George Town, 10990
    Malaysia

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  • Research Site

    Dyer, Indiana 46311
    United States

    Site Not Available

  • Research Site

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Research Site

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge, Louisiana 70817
    United States

    Active - Recruiting

  • Research Site

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Research Site

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Research Site

    Traverse City, Michigan 49684
    United States

    Active - Recruiting

  • Research Site

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Research Site

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Research Site

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Research Site

    Henderson, Nevada 89074
    United States

    Active - Recruiting

  • Research Site

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Research Site

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Research Site

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • Research Site

    Commack, New York 11725
    United States

    Site Not Available

  • Research Site

    New York, New York 10065
    United States

    Active - Recruiting

  • Research Site

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Research Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Research Site

    Blue Ash, Ohio 45242
    United States

    Active - Recruiting

  • Research Site

    Canton, Ohio 44710
    United States

    Active - Recruiting

  • Research Site

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97223
    United States

    Active - Recruiting

  • Research Site

    Horsham, Pennsylvania 19044
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Research Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Research Site

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Research Site

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Research Site

    Flower Mound, Texas 75028
    United States

    Active - Recruiting

  • Research Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Irving, Texas 75063
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Research Site

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Research Site

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Research Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Research Site

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Research Site

    Winchester, Virginia 22601
    United States

    Active - Recruiting

  • Research Site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Research Site

    Madison, Wisconsin 53715
    United States

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh city, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Vinh, 460000
    Vietnam

    Active - Recruiting

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