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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04290793
• Other study ID #: HRHB-CB001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2020
• Source: Hebei Medical University Fourth Hospital
• Contact: YUNJIANG LIU, PHD.
• Phone: 86095588
• Email: lyj818326[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib
400mg administered as continuous oral once daily from the first day of the study
• Epirubicin
90mg/m^2 d1 iv Q2W for 4 cycles
• Cyclophosphamide
600 mg/m^2 d1 iv Q2W for 4 cycles
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response rate(pCR)	pathological complete response	within 3 weeks after surgery
Secondary	Objective Response Rate(ORR)	Baseline to measured stable disease	2 years
Secondary	Event Free Survival(EFS)	Baseline to the occurrence of any event	3 years
Secondary	Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause	Baseline to measured date of recurrence or death from any cause	3 years
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	5 years