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

Description

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Daphne

Research Site, Daphne, Alabama, United States, 36526

Goodyear

Research Site, Goodyear, Arizona, United States, 85395

Phoenix

Research Site, Phoenix, Arizona, United States, 85054

Tucson

Research Site, Tucson, Arizona, United States, 85711

Jonesboro

Research Site, Jonesboro, Arkansas, United States, 72401

Rogers

Research Site, Rogers, Arkansas, United States, 72758

Bakersfield

Research Site, Bakersfield, California, United States, 93309

Fullerton

Research Site, Fullerton, California, United States, 92835

Irvine

Research Site, Irvine, California, United States, 92612

Los Angeles

Research Site, Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be ≥ 18 years, at the time of signing the ICF.
  • * Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC 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 regulations regarding the methods of contraception for those participating in clinical studies.
  • * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
  • * 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
  • * Resting ECG with clinically significant abnormal findings.
  • * Uncontrolled or significant cardiac disease.
  • * History of non-infectious ILD/pneumonitis
  • * Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
  • * For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
  • * Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2030-08-28