A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1192
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients, 18 years ≤ age ≤ 75 years；
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive HER2 positive breast cancer.
• Known hormone receptor status.
• Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
• Been treated for early breast cancer with standard of care duration of trastuzumab.
• If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response.
• Signed informed consent form (ICF) .

Exclusion Criteria:

• Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
• History of heart disease.
• Bilateral breast cancer.
• Corrected QT (QTc) interval ≥0.47 seconds.
• History of gastrointestinal disease with diarrhea as the major symptom.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm Pyrotinib; Intervention: Drug: Pyrotinib	Drug: Pyrotinib; pyrotinib 400 mg, orally once daily for one year
Placebo Comparator: Arm Placebo; Intervention: Drug: Placebo	Drug: Placebo; placebo 400mg, orally once daily for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease-free Survival (iDFS)	Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.	From randomization until time of event up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause.	From randomization until time of event up to 2 years
Overall Survival (OS)	Overall survival is defined as the time from randomization to death from any cause.	up to 2 years
Distance Disease-free Survival (DDFS)	Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.	distant recurrence From randomization until time of event up to 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Study Chair: Zhimin Shao, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HR-BLTN-III-EBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No