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NCT Number: NCT03588091

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

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.

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Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pyrotinib

Drug

pyrotinib: 400mg orally daily;

Placebo oral tablet

Drug

placebo: 400mg orally daily;

Trastuzumab

Drug

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

docetaxel

Drug

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

Primary outcomes

  1. Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites

    Time frame: 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)

  2. Event-free survival(EFS)

    Time frame: Following surgery until Year 3

  3. Disease-free Survival (DFS)

    Time frame: Following surgery until Year 3

  4. Distance Disease-free Survival (DDFS)

    Time frame: Following surgery until Year 3

  5. Objective Response Rate (ORR) during neoadjuvant period

    Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2018
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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