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)
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 625 (estimated)
- Sponsor
- AstraZeneca · Industry
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.
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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Check Your EligibilityThis 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.
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AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
CONTACT