Actively Recruiting
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
Led by D'Or Institute for Research and Education · Updated on 2026-04-01
40
Participants Needed
5
Research Sites
139 weeks
Total Duration
On this page
Sponsors
D
D'Or Institute for Research and Education
Lead Sponsor
G
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary invasive breast carcinoma.
- Clinical stage T1c N0 M0 with any level of TILs or clinical stage T2 N0 M0 with TILs 50% or more.
- Estrogen receptor (ER) and progesterone receptor (PR) expression less than 10%.
- HER2-negative or non-amplified according to ASCO-CAP criteria.
- No distant metastasis confirmed by imaging (CT scan or FDG PET-CT).
- Age 18 years or older.
- ECOG performance status between 0 and 2.
- Adequate organ function.
You will not qualify if you...
- Uncontrolled severe health conditions such as active 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 individuals.
- History of severe allergic reactions to platinum-based agents or taxanes, including anaphylaxis or other hypersensitivity reactions.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Instituto D'Or de Pesquisa e Ensino de Brasília
Brasília, Brazil
Actively Recruiting
2
Instituto D'Or de Pesquisa e Ensino de Curitiba
Curitiba, Brazil
Not Yet Recruiting
3
Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro
Rio de Janeiro, Brazil
Actively Recruiting
4
Instituto D'Or de Pesquisa e Ensino de Salvador
Salvador, Brazil
Actively Recruiting
5
Instituto D'Or de Pesquisa e Ensino de São Paulo
São Paulo, Brazil
Actively Recruiting
Research Team
I
Intituto D'Or de Pesquisa e Ensino São Paulo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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