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

NCT03588091 | Completed Phase 3 FDA Drug

• 1 other identifier: HR-BLTN-III-NeoBC
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Event-free survival(EFS)

  Following surgery until Year 3

• Disease-free Survival (DFS)

  Following surgery until Year 3

• Distance Disease-free Survival (DDFS)

  Following surgery until Year 3

• 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

Study Arms (2)

arm1

EXPERIMENTAL

Pyrotinib Plus trastuzumab and docetaxel

Drug: Pyrotinib; Drug: Trastuzumab; Drug: Docetaxel

arm2

PLACEBO COMPARATOR

placebo plus trastuzumab and docetaxel

Drug: Placebo Oral Tablet; Drug: Trastuzumab; Drug: Docetaxel

Interventions

Pyrotinib DRUG

pyrotinib: 400mg orally daily;

arm1

Placebo Oral Tablet DRUG

placebo: 400mg orally daily;

arm2

Trastuzumab DRUG

trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;

arm1; arm2

Docetaxel DRUG

docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles

arm1; arm2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (17)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Sun Yet-Sen University Cancer Center

Guangzhou, Guangdong, 510010, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510289, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Huai'an First People's Hospital

Huaian, Jiangsu, 223001, China

Location

JiangSu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250000, China

Location

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, 266100, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xian, Shanxi, 710004, China

Location

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Wu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3.

  PMID: 36575513 DERIVED

MeSH Terms

Interventions

pyrotinib; Trastuzumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 17, 2018
• Study Start: July 24, 2018
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (17)