De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC

NCT06692725 | Recruiting

• 1 other identifier: PKUPH2024Z160
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

neoadjuvant chemotherapy; De-escalation

Outcome Measures

Primary Outcomes (1)

• pathology complete response

  Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)

  6 months

Secondary Outcomes (4)

• Invasive disease free survival

  5 years

• Disease free survival

  5 years

• Breast cancer specific survival

  5 years

• Overall survival

  5 years

Study Arms (2)

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

triple negative breast cancer patients who received neoadjuvant chemotherapy based on taxanes combined with carboplatin

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor paraffin sample for each patient

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• shu wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)