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NCT Number: NCT06692725

De-escalation of Neoadjuvant Chemotherapy Regimens 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

shu wang

PRINCIPAL_INVESTIGATOR

yuan peng, doctor

CONTACT

About this study

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

  • 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.

Exclusion criteria

  • 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

Primary end point: pathology complete response

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. pathology complete response

    Time frame: 6 months

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

Secondary outcomes

  1. Invasive disease free survival

    Time frame: 5 years

    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.

  2. Disease free survival

    Time frame: 5 years

    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.

  3. Breast cancer specific survival

    Time frame: 5 years

    time from study enrollment to death due to breast cancer.

  4. Overall survival

    Time frame: 5 years

    the time from study enrollment to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: NacTNBC

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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