De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients

Recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT06700369
• Lead Sponsor: Shu Wang

Brief Summary

Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.

This project plans to a 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 patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.

Detailed Description

(1) Inclusion criteria:

1. Patients with HER2 positive breast cancer were 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 metastasis);

3. Received treatment in Peking University People's hospital and had hospitalization records;

4. Has signed and agreed to participate in the PKUPH breast disease cohort study.

(2) 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. Received any other anti-tumor therapy, including endocrine therapy, or immunotherapy;

4. Receiving other chemo-regimens.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

• 1. Patients with HER2 positive 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pathology complete response	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 Outcome Measures

Name	Time	Method
Invasive disease free survival	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.
Disease free survival	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.
Breast cancer specific survival	5 years	time from study enrollment to death due to breast cancer.
Overall survival	5 years	the time from study enrollment to death from any cause

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China