Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Docetaxel

Cyclophosphamide

Epirubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Experimental: Patients will receive Pyrotinib combined with Epirubicin and Cyclophosphamide followed by Docetaxel

Drug: Pyrotinib pyrotinib 320mg orally daily Drug: Epirubicin epirubicin 90mg/m\^2 d1 iv Q3W for 4 cycles Drug: Cyclophosphamide cyclophosphamide 600mg/m\^2 d1 iv Q3W for 4 cycles Drug: Docetaxel docetaxel 100mg/m\^2 d1 iv Q3W for 4 cycles

Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

Gong Chang, doctor

This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR positive and HER2-low-expressing early or locally advanced breast cancer.

Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

The percentage of patients with RCB-0/1 after neoadjuvant therapy

The percentage of patients with pCR (ypT0/is, ypN0) after neoadjuvant therapy

The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy 【(CR+PR)/Analysis of the total number of people】

The breast conservation rate after treatment.

The DFS is defined as the time from registration until any relapse, secondary malignancy, or death from any cause

The OS is defined as the time from registration to death, irrespective of cause.

Diarrhea were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial	NCT05165225	Breast Cancer HER2-low-expres... Hormone Recepto... Neoadjuvant The...	Pyrotinib + epi...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial	NCT05165225	Breast Cancer HER2-low-expres... Hormone Recepto... Neoadjuvant The...	Pyrotinib + epi...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment