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

A Cohort Study of Different Choice of Adjuvant Therapy in Non-PCR Patients With HER2 Positive Early Breast Cancer After Neoadjuvant Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer

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 Type: Observational
• Enrollment (Estimated): 2092

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
      • Contact: yuan peng, Dr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

HER2 positive breast cancer patients with residual invasive breast cancer after neoadjuvant chemotherapy combined with trastuzumab and pertuzumab

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Trastuzumab combined with pertuzumab; The postoperative adjuvant regimen was trastuzumab combined with pertuzumab, and the planned treatment duration was 1 year
T-DM1; The postoperative adjuvant regimen was T-DM1, and the planned treatment duration was 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease free survival	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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	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 years
distant disease free survival	Time from study enrollment to distant recurrence and metastasis	3 years
breast cancer specific survival	Time from study enrollment to death due to breast cancer	3 years
overall survival	Time from study enrollment to death from any cause	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

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; T-DM1; non-pCR
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PKUPH2024Z169

Drug and device information, study documents

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