NCT03756064

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer: a Single-arm, Ahead, Open-label Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Detailed description

The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy. It is proposed that 100 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.

Conditions

• Breast Cancer
• Neoplasm, Breast
• Breast Diseases

Interventions

Type	Name	Description
DRUG	Pyrotinib	Pyrotinib: 400mg orally daily
DRUG	Trastuzumab	Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;
DRUG	Docetaxel	Docetaxel: 75mg/m2 for a total of 6 cycles
DRUG	Carboplatin	Carboplatin: AUC=5 for a total of 6 cycles
DRUG	Placebo Oral Tablet	Placebo Oral Tablet: 400mg orally daily

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-07-31
• Completion: 2021-07-31
• First posted: 2018-11-28
• Last updated: 2019-08-13

Locations

1 site across 1 country: China