Reducing chemotherapy for triple negative breast cancer with immunotherapy

De-escalation of Neoadjuvant Chemotherapy Regimens (Taxane Plus Carboplatin Versus Taxane Plus Carboplatin Sequential Anthracycline) With Immunotherapy Among TNBC

This study is testing whether giving less chemotherapy along with immunotherapy can help people with triple negative breast cancer respond better to treatment.

Quick facts

• Study type: Observational
• Enrollment: 380 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: pabolizumab, chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06692725 on ClinicalTrials.gov

What this trial studies

This project investigates the effectiveness and safety of de-escalating neoadjuvant chemotherapy regimens combined with immunotherapy for patients with triple negative breast cancer (TNBC). It utilizes a large cohort database from Peking University People's Hospital, including both retrospective and prospective patient data. The study focuses on patients with clinical stage T2 and above or lymph node positive TNBC who received various neoadjuvant therapies. The primary endpoint is to evaluate the pathological complete response (pCR) among different treatment regimens.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with stage II or III triple negative breast cancer who have received neoadjuvant therapy at Peking University People's Hospital.

Not a fit: Patients with metastatic breast cancer or those receiving other anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for patients with triple negative breast cancer.

How similar studies have performed: While the approach of combining immunotherapy with chemotherapy is gaining traction, this specific de-escalation strategy is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 1\) Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
* 2\) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
* 3\) Received treatment in our hospital and had hospitalization records;
* 4\) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

* 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2\) Patients with metastatic breast cancer or bilateral breast cancer;
* 3\) At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
* 4\) Receiving other regimens besides the established neoadjuvant regimens

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: shu wang — Peking University People's Hospital
• Study coordinator: yuan peng, doctor

Conditions: Triple Negative Breast Cancer, neoadjuvant chemotherapy, De-escalation