TIL-guided lower-intensity chemotherapy for early triple-negative breast cancer
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 trial tests whether some women with stage I–II triple-negative breast cancer can safely receive shorter, less intensive chemotherapy based on tumor-infiltrating lymphocyte levels and imaging response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | D'Or Institute for Research and Education Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, cyclophosphamide |
| Locations | 5 sites (Brasília and 4 other locations) |
| Trial ID | NCT07074106 on ClinicalTrials.gov |
What this trial studies
This is a single-arm phase II trial that uses tumor-infiltrating lymphocytes (TILs) and radiologic response to guide neoadjuvant chemotherapy intensity in stage I–II triple-negative breast cancer. Eligible patients (stage I regardless of TILs, and stage II with TILs ≥50%) receive four cycles of carboplatin plus a taxane; patients with a complete radiologic response proceed directly to surgery. Those without a complete radiologic response are escalated to anthracycline plus cyclophosphamide, with the option to add pembrolizumab. The primary endpoint is pathological complete response, with secondary endpoints including correlation of radiologic and pathologic response, event-free survival, and overall survival.
Who should consider this trial
Good fit: Women aged 18 or older with histologically confirmed invasive stage I (T1c N0 M0) TNBC or stage II (T2 N0 M0) TNBC with TILs ≥50%, ER/PR <10%, HER2-negative, ECOG 0–2, adequate organ function, and no distant metastasis are eligible.
Not a fit: Patients with stage II disease and low TILs (<50%), those with metastatic disease, pregnant or breastfeeding individuals, or those with uncontrolled severe comorbidities are unlikely to benefit from the de-escalation strategy.
Why it matters
Potential benefit: If successful, this approach could allow some patients to avoid more toxic chemotherapy (such as anthracyclines) while preserving high cure rates.
How similar studies have performed: Prior studies have shown that high TIL levels correlate with better chemotherapy responses and de-escalation strategies are being explored, but TIL-guided de-escalation with optional pembrolizumab in early TNBC is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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. * Pregnant or breastfeeding participants. * History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
Where this trial is running
Brasília and 4 other locations
- Instituto D'Or de Pesquisa e Ensino de Brasília — Brasília, Brazil (Recruiting)
- Instituto D'Or de Pesquisa e Ensino de Curitiba — Curitiba, Brazil (Not_yet_recruiting)
- Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro — Rio de Janeiro, Brazil (Recruiting)
- Instituto D'Or de Pesquisa e Ensino de Salvador — Salvador, Brazil (Recruiting)
- Instituto D'Or de Pesquisa e Ensino de São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Intituto D'Or de Pesquisa e Ensino São Paulo
- Email: oncologia.projetos@idor.org
- Phone: pesquisaclinica@idor.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.