De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC (NacTNBC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer

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

• Study Type: Observational
• Enrollment (Estimated): 380

Contacts and Locations

• Study Contact: Name: yuan peng, doctor; Phone Number: 86+13671287670; Email: 13671287670@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Principal Investigator: Shu Wang
      • Contact: yuan peng, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive disease free survival	the time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.	5 years
Disease free survival	the time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.	5 years
Breast cancer specific survival	time from study enrollment to death due to breast cancer.	5 years
Overall survival	the time from study enrollment to death from any cause	5 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: shu wang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; De-escalation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: PKUPH2024Z160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No