Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Trastuzumab

Cyclophosphamide

Albumin-Bound Paclitaxel

Epirubicin

Mitogens

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Prior to surgery: pyrotinib and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.

Prior to surgery: trastuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.

Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.

Pyrotinib

Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.

nab-Paclitaxel

Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 9, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab

epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks 4 cycles (Cycles 5-8)

EC chemotherapy

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Surgery

Kunwei Shen, MD

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab.

Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer

The percentage of participants who experienced at least one adverse event during the neoadjuvant period, surgery, adjuvant treatment period.

tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer \[AJCC\] staging system).The duration of one treatment cycle is 21 days.

bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).The duration of one treatment cycle is 21 days.

Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The duration of one treatment cycle is 21 days.

EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause.

DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery. Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause.

OS was defined as the time from randomization to death from any cause.

Jiangsu HengRui Medicine Co., Ltd.

Shanghai Jiao Tong University School of Medicine

Professor

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Fatigue

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Herbal and Botanical

Astragalus

PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle

Astragalus polysaccharides 500 mg

500 ml saline, 3 days via i.v. infusion per chemotherapy cycle

Placebo

Epirubicin plus Cyclophosphamide every 21 days

EC Chemotherapy

Kun-Ming Rau, MD

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	NCT04066790	Breast Cancer	Pyrotinib nab-Paclitaxel Trastuzumab EC chemotherapy Surgery	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy	NCT03314805	Cancer-related ... Neutropenia, Ma...	Astragalus poly... Placebo EC Chemotherapy	20 Years -	PhytoHealth Corporation
PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy	NCT03314805	Cancer-related ... Neutropenia, Ma...	Astragalus poly... Placebo EC Chemotherapy	20 Years -	PhytoHealth Corporation

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