Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy (TaxDHER2)

Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate 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 trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. 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): 8077

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; Phone Number: 86+13671287670

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, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative).

Description

Inclusion Criteria:

• 1) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
• 2) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
• 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion Criteria:

• 1) Lack of clinical pathological data (such as imaging data, pathological data);
• 2) Preoperative neoadjuvant therapy;
• 3) Patients with metastatic breast cancer or bilateral breast cancer;
• 4) Failed to undergo curative surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Taxanes combined with cyclophosphamide chemotherapy; Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), cyclophosphamide chemotherapy, combined with targeted therapy with trastuzumab, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year
Taxanes chemotherapy; Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel) combined with trastuzumab and pertuzumab targeted therapy, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	The time from 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease free survival	The time from 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
distant disease free survival	The time from enrollment in the study to the occurrence of distant recurrence and metastasis	3 years
breast cancer specific survival	Time from enrollment to death due to breast cancer	3 years
overall survival	The time from enrollment in the study to death caused by any reason	3 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: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: target therapy; Taxane
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PKUPH2024Z165

Drug and device information, study documents

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