Lighter, Personalized Chemotherapy for Early Triple-Negative Breast Cancer
Tests adjusted chemotherapy in adults with early triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
Key facts
- Where
- Brasília, Curitiba, Rio de Janeiro, Salvador, and São Paulo, BrazilSee the 5 sites
- Phase
- Phase 2
Where in Brazil
- Instituto D'Or de Pesquisa e Ensino de BrasíliaBrasília, BrazilTaking people
- 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, BrazilTaking people
- Instituto D'Or de Pesquisa e Ensino de SalvadorSalvador, BrazilTaking people
- Instituto D'Or de Pesquisa e Ensino de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- D'Or Institute for Research and Education
- Trial code
- NCT07074106
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
DespaTIL Study: A Phase II Trial of De-escalated Neoadjuvant Chemotherapy for Early-Stage Triple-Negative Breast Cancer Guided by Tumor-Infiltrating Lymphocytes (TILs) and Radiologic Response
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.
Inclusion: Histologically confirmed primary invasive breast carcinoma; One of the following conditions:; Clinical stage T1c N0 M0 with any level of TILs; or; Clinical stage T2 N0 M0 with TILs ≥ 50%; Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%; HER2-negative or non-amplified, according to current ASCO-CAP criteria; No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT); Age ≥ 18 years; ECOG performance status of 0 to 2; Adequate organ function.
Exclusion: The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease; History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes; Pregnant or breastfeeding participants.