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

NCT06722612 | Recruiting

• 1 other identifier: PKUPH2024Z166
• Study Type: observational
• Target: 2,916
• 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 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.

Conditions

HER2-positive Breast Cancer

Keywords

Taxane; target therapy; carboplatin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• invasive disease free survival

  5 years

• distant disease free survival

  5 years

• breast cancer specific survival

  5 years

• overall survival

  5 years

Study Arms (2)

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.

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

You may qualify if:

• \) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
• \) 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);
• \) 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);
• \) Preoperative neoadjuvant therapy;
• \) Patients with metastatic breast cancer or bilateral breast cancer;
• \) Failure to perform radical 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: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CN (1)