Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate 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 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.

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

• 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.

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: 8077
Treatments
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
Sponsors
Leads: Shu Wang

This content was sourced from clinicaltrials.gov