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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
yuan peng, doctor
13671287670@163.com
86+13671287670
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 2916
Treatments
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.
Sponsors
Leads: Shu Wang

This content was sourced from clinicaltrials.gov