De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC

NCT ID: NCT06692725

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2028-12-31

Brief Summary

The traditional neoadjuvant therapy for triple negative breast cancer is based on anthracycline, paclitaxel and carboplatin. Nowadays, immunotherapy combined with chemotherapy has become a new standard treatment, which not only benefits from pathological complete response (pCR), but also benefits from long-term survival. The standard chemotherapy combined with immunotherapy scheme recommended by the guidelines is TCb-AC combined with pabolizumab, but the complex chemotherapy scheme has the defects of long cycle and large adverse reactions, and the scheme of chemotherapy reduction has been explored.

This project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, or TCb combined with immunotherapy) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.

Detailed Description

Investigators retrospectively recruited the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, TCb combined with immunotherapy, or TCb chemotherapy only) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.

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

Primary end point: pathology complete response

Conditions

Triple Negative Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Taxanes combined with carboplatin sequential anthracycline

Paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 4 cycles, followed by anthracycline combined with cyclophosphamide for 4 cycles, and PD-1 inhibitor was used at the same time

No interventions assigned to this group

Taxanes combined with carboplatin

paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 6 cycles, and PD-1 inhibitor was used at the same time

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shu Wang

director of breast center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shu wang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

yuan peng, doctor

Role: CONTACT

13671287670@163.com

86+13671287670

Facility Contacts

yuan peng, doctor

Role: primary

Other Identifiers

PKUPH2024Z160

Identifier Type: -

Identifier Source: org_study_id