Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

• Sponsor: Hebei Medical University Fourth Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04290793
• Collaborator: (none)
• Enrollment: 280
• Arms: 2
• Anticipated Duration (Months): 48

Study Details

Study Description

Brief Summary

This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Pyrotinib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Taxanes; Biological: Trastuzumab	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab	Drug: Pyrotinib; 400mg administered as continuous oral once daily from the first day of the study; Drug: Epirubicin; 90mg/m^2 d1 iv Q2W for 4 cycles; Drug: Cyclophosphamide; 600 mg/m^2 d1 iv Q2W for 4 cycles; Drug: Taxanes; Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles ); Biological: Trastuzumab; the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year
Active Comparator: Control group Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab	Drug: Epirubicin; 90mg/m^2 d1 iv Q2W for 4 cycles; Drug: Cyclophosphamide; 600 mg/m^2 d1 iv Q2W for 4 cycles; Drug: Taxanes; Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles ); Biological: Trastuzumab; the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year

Outcome Measures

Primary Outcome Measures

1. Pathological Complete Response rate(pCR) [within 3 weeks after surgery]

   pathological complete response

Secondary Outcome Measures

1. Objective Response Rate(ORR) [2 years]

   Baseline to measured stable disease

2. Event Free Survival(EFS) [3 years]

   Baseline to the occurrence of any event

3. Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause [3 years]

   Baseline to measured date of recurrence or death from any cause

4. Overall survival (OS) [5 years]

   Baseline to measured date of death from any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment；

2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；

3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；

4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；

5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^{9/L; platelet count (PLT) ≥ 90 × 10}9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;

6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;

7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.

Exclusion Criteria:

1. Known history of hypersensitivity to pyrotinib or any of it components;

2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);

3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;

4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;

5. Patients with severe heart disease or discomfort who cannot be treated;

6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;

7. Pregnant or lactating women;

8. Less than 4 weeks from the last clinical trial;

9. Patients participating in other clinical trials at the same time

10. The researchers think inappropriate.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hebei Medical University Fourth Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu Yunjiang, Director, Hebei Medical University Fourth Hospital
• ClinicalTrials.gov Identifier: NCT04290793
• Other Study ID Numbers: HRHB-CB001
• First Posted: Mar 2, 2020
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Cyclophosphamide; Trastuzumab; Epirubicin; Taxane

Study Results

No Results Posted as of Mar 2, 2020