Dato-DXd for PD-L1 Positive Triple-negative Breast Cancer

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
625 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for patients with a specific type of breast cancer that is not treatable by surgery. Participants will receive a treatment called Dato-DXd, with or without another drug, or a standard chemotherapy treatment.

Are You a Good Fit for This Trial?
Rules you out Autoimmune disordersPulmonary issuesSevere infections

You may be able to join if

  • I have been diagnosed with locally recurrent or metastatic triple-negative breast cancer.
  • I have a PD-L1 positive test result.
  • I have not received any prior chemotherapy for my breast cancer.
  • I am able to provide a sample of my tumor.
  • I am at least 6 months post-treatment for earlier stage breast cancer, if applicable.
  • I have measurable cancer that can be evaluated.
  • I am in good overall health with stable organ function.
  • I agree to use contraception if I can become pregnant.

You may not be able to join if

  • I have uncontrolled medical conditions that would make it unsafe for me to participate.
  • I have another active cancer besides skin cancer treated with curative intent in the past 2 years.
  • I have untreated infections needing strong antibiotics.
  • I have active hepatitis B or C.
  • I have uncontrolled heart disease.
  • I have a history of severe lung issues requiring steroid treatment.
  • I have a severe allergy to drugs similar to Dato-DXd.
  • I am pregnant, breastfeeding or planning to become pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria * Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines. * ECOG PS 0 or 1. * Participants are expected to provide an FFPE tumour sample collected from a …
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT

AstraZeneca Breast Cancer Study Locator Service

+1-877-400-4656

az-bcsl@careboxhealth.com

CONTACT