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

NCT06693037 | Recruiting

• 1 other identifier: PKUPH2024Z169
• Study Type: observational
• Target: 2,092
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Keywords

neoadjuvant chemotherapy; non-pCR; T-DM1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• disease free survival

  3 years

• distant disease free survival

  3 years

• breast cancer specific survival

  3 years

• overall survival

  3 years

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \) Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
• \) The clinical stages before treatment were T1-T4, N0-N3, M0;
• \) Received treatment and operation in our hospital, and had hospitalization records;
• \) Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy
• \) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;
• \) Has signed and agreed to participate in the PKUPH breast disease cohort study.

You may not qualify if:

• \) Lack of clinical and pathological data (such as imaging data and pathological data);
• \) Patients with metastatic breast cancer or bilateral breast cancer;
• \) Failure to perform radical surgery;
• \) Receiving other regimens besides the established neoadjuvant regimens.

Sponsors & Collaborators

• Shu Wang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor paraffin sample for each patient

Study Officials

• shu wang, doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)