Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03588091
• Other study ID #: HR-BLTN-III-NeoBC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 24, 2018
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 355
• Est. completion date: June 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• female patients, 18 years = age = 75 years;

• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1

• Histologically confirmed invasive breast cancer(early stage or locally advanced):Primary tumour greater than 2 cm diameter

• HER2 positive (HER2+++ by IHC or FISH+)

• Known hormone receptor status.

• Cardiovascular:Baseline left ventricular ejection fraction (LVEF)=55% measured by ECHO

• Signed informed consent form (ICF)

Exclusion Criteria:

• metastatic disease (Stage IV) or inflammatory breast cancer

• Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.

• clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension =180/110);

• Unable or unwilling to swallow tablets.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Pyrotinib
pyrotinib: 400mg orally daily;
• Placebo Oral Tablet
placebo: 400mg orally daily;
• Trastuzumab
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
• Docetaxel
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	The Fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yet-Sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Huai'an First People's Hospital	Huaian	Jiangsu
China	Shandong Cancer Hospital	Jinan	Shandong
China	JiangSu Province Hospital	Nanjing	Jiangsu
China	The Affiliated Hospital Of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Affiliated Hospital Of Xi'an Jiaotong University	Xian	Shanxi
China	The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)		through study completion, an average of 1 year
Secondary	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites		Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days)
Secondary	Event-free survival(EFS)		Following surgery until Year 3
Secondary	Disease-free Survival (DFS)		Following surgery until Year 3
Secondary	Distance Disease-free Survival (DDFS)		Following surgery until Year 3
Secondary	Objective Response Rate (ORR) during neoadjuvant period		Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months