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

NCT07074106 | Recruiting Phase 2

• 1 other identifier: 831-25-ONCOLOGIA-IDOR-SP-M-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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

Breast Cancer

Keywords

TILs; Breast cancer; radiological response; Descalonation of neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel.

  3 mo

Study Arms (1)

Carboplatin and Taxane - 4 Cycles

EXPERIMENTAL

All patients will receive Carboplatin and a Taxane for 4 cycles. Patients who achieve a complete radiological response will proceed directly to surgery. Those without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.

Drug: Carboplatin and a Taxane

Interventions

Carboplatin and a Taxane DRUG

All patients will receive Carboplatin and a Taxane for 4 cycles. * Patients who achieve a complete radiological response will proceed directly to surgery. * Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.

Carboplatin and Taxane - 4 Cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM): collaborator
• D'Or Institute for Research and Education: lead

Study Sites (5)

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Intituto D'Or de Pesquisa e Ensino São Paulo

CONTACT

pesquisaclinica@idor.org; oncologia.projetos@idor.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)