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

ConditionBreast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorD'Or Institute for Research and Education

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Carboplatin and Taxane - 4 CyclesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

3 mo

Sponsors and contacts

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D'Or Institute for Research and Education

Lead sponsor

Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Collaborator

Source ClinicalTrials.gov

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