NCT07074106RecruitingPhase 2
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 31 Oct 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- D'Or Institute for Research and Education
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07074106
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 31 Oct 2025 to the primary completion date, 1 Jul 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
Other
- Pregnant or breastfeeding participants.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto D'Or de Pesquisa e Ensino de Brasília Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Instituto D'Or de Pesquisa e Ensino de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Not yet recruiting |
| Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Instituto D'Or de Pesquisa e Ensino de Salvador Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Instituto D'Or de Pesquisa e Ensino de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.