Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer (TaxCbHER2)

Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 2916

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, doctor

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative)

Description

Inclusion Criteria:

• 1) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
• 2) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
• 3) 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) Preoperative neoadjuvant therapy;
• 3) Patients with metastatic breast cancer or bilateral breast cancer;
• 4) Failure to perform radical surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Taxanes combined with carboplatin; Paclitaxel drugs (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), carboplatin chemotherapy, combined with targeted therapy with trastuzumab, for a total of 6 cycles, followed by targeted therapy with trastuzumab for 1 year.
Taxanes; Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), combined with targeted therapy with trastuzumab and pertuzumab, for a total of 6 cycles, followed by targeted therapy with trastuzumab and pertuzumab for 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease free survival	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.	5 years
distant disease free survival	Time from study enrollment to distant recurrence and metastasis	5 years
breast cancer specific survival	Time from study enrollment to death due to breast cancer	5 years
overall survival	Time from study enrollment to death from any cause	5 years

Collaborators and Investigators

• Sponsor: Shu Wang

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: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: carboplatin; target therapy; Taxane
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PKUPH2024Z166

Drug and device information, study documents

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