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

NCT06711068 | Recruiting

• 1 other identifier: PKUPH2024Z165
• Study Type: observational
• Target: 8,077
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Keywords

Taxane; target therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• invasive disease free survival

  3 years

• distant disease free survival

  3 years

• breast cancer specific survival

  3 years

• overall survival

  3 years

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

• \) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
• \) 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);
• )Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

You may not qualify if:

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

Sponsors & Collaborators

• Shu Wang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

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 26, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)