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

NCT ID: NCT07074106

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-07-01

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.

Detailed Description

This is a phase II, single-arm clinical trial investigating a de-escalated neoadjuvant chemotherapy regimen for stage I and II triple-negative breast cancer (TNBC), guided by tumor-infiltrating lymphocytes (TILs) and radiologic response.

Patients with stage I TNBC (regardless of TIL levels) and stage II TNBC with TILs ≥ 50% will receive four cycles of carboplatin and a taxane. Those who achieve a complete radiologic response will proceed to surgery, while patients without a complete radiologic response will be escalated to a regimen including anthracycline and cyclophosphamide, with or without pembrolizumab.

The primary objective is to evaluate the pathological complete response rate. Secondary outcomes include the correlation between radiologic and pathologic response, event-free survival, and overall survival.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin and Taxane - 4 Cycles

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.

Group Type: EXPERIMENTAL

Carboplatin and a Taxane

Intervention Type: 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.

Interventions

Carboplatin and a Taxane

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

UNKNOWN

Sponsor Role: collaborator

D'Or Institute for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto D'Or de Pesquisa e Ensino de Brasília

Brasília, , Brazil

Instituto D'Or de Pesquisa e Ensino de Curitiba

Curitiba, , Brazil

Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro

Rio de Janeiro, , Brazil

Instituto D'Or de Pesquisa e Ensino de Salvador

Salvador, , Brazil

Instituto D'Or de Pesquisa e Ensino de São Paulo

São Paulo, , Brazil

Countries

Brazil

Central Contacts

Intituto D'Or de Pesquisa e Ensino São Paulo

Role: CONTACT

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Facility Contacts

Role: primary

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Role: primary

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Role: primary

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Role: primary

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Role: primary

oncologia.projetos@idor.org

pesquisaclinica@idor.org

Other Identifiers

831-25-ONCOLOGIA-IDOR-SP-M-I

Identifier Type: -

Identifier Source: org_study_id