Adjuvant Therapy Choice for Non-pCR HER2 Positive Early Breast Cancer After Neoadjuvant Therapy

Recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT06693037
• Lead Sponsor: Shu Wang

Brief Summary

Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. The survival rate of patients with pathological complete response (PCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-PCR. Therefore, studies have confirmed that adjuvant therapy for patients with non-PCR after neoadjuvant chemotherapy can further improve the prognosis and survival of this population. However, the results of previous studies are based on trastuzumab target therapy in neoadjuvant therapy. Therefore, there are different recommendations for the current guidelines of adjuvant therapy after trastuzumab combined pertuzumab target neoadjuvant therapy. Patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology. The effect of postoperative adjuvant therapy with trastuzumab and patuzumab or replacement of T-DM1 on survival.

Detailed Description

Investigators retrospectively recruited patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology from January 1, 2019 to November 31, 2024, and prospectively recruit patients of the same type from December 1, 2024 to December 31, 2028.

Inclusion Criteria:

1. Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;

2. The clinical stages before treatment were T1-T4, N0-N3, M0;

3. Received treatment and operation in our hospital, and had hospitalization records;

4. Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy

5. Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;

6. 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. Failure to perform radical surgery;

4. Receiving other regimens besides the established neoadjuvant regimens.

The therapy choice Arm 1: The postoperative adjuvant regimen is a combination of trastuzumab and pertuzumab, with a planned treatment duration of 1 year; Arm 2: Postoperative adjuvant therapy was T-DM1, with a planned treatment duration of 1 year.

Primary end point 3-years invasive disease free survival

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2092

Inclusion Criteria

• 1. Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
• 2. The clinical stages before treatment were T1-T4, N0-N3, M0;
• 3. Received treatment and operation in our hospital, and had hospitalization records;
• 4. Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy
• 5. Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;
• 6. 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. Failure to perform radical surgery;
• 4. Receiving other regimens besides the established neoadjuvant regimens.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
invasive disease free survival	3 years	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

Secondary Outcome Measures

Name	Time	Method
disease free survival	3 years	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
distant disease free survival	3 years	Time from study enrollment to distant recurrence and metastasis
breast cancer specific survival	3 years	Time from study enrollment to death due to breast cancer
overall survival	3 years	Time from study enrollment to death from any cause

Trial Locations

Locations (1)

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