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Study identifier: NCT07074106 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC

Condition: Breast Cancer  ·  Sponsor: D'Or Institute for Research and Education

PhasePhase 2
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment. Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles. If imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer. The main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.

This description comes directly from the study's public registry record.

Talk to the study team

Intituto D'Or de Pesquisa e Ensino São Paulo  ·  pesquisaclinica@idor.org  ·  oncologia.projetos@idor.org

Always discuss trial participation with your own doctor first.

Locations (5)

Instituto D'Or de Pesquisa e Ensino de BrasíliaBrasília, BrazilRecruiting
Instituto D'Or de Pesquisa e Ensino de CuritibaCuritiba, BrazilNot Yet Recruiting
Instituto D'Or de Pesquisa e Ensino do Rio de JaneiroRio de Janeiro, BrazilRecruiting
Instituto D'Or de Pesquisa e Ensino de SalvadorSalvador, BrazilRecruiting
Instituto D'Or de Pesquisa e Ensino de São PauloSão Paulo, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT07074106