Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (ATP)

Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Breast Cancer
• Intervention / Treatment: Drug: pyrotinib

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wenjin Yin; Phone Number: 86(21)68385569; Email: followroad@163.com
• Study Contact Backup: Name: Qi Lu; Phone Number: 86(21)68383364; Email: rjllb3364@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Jinsong Lu, MD; Email: lujjss@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female, Aged ≥18 and ≤70 years;
• Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
• Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
• Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
• Been or being treated for early breast cancer with standard of care duration of trastuzumab;
• Adjuvant treatment regimen needs to be determined before randomization;
• Duration from Random time to the last use of trastuzumab≤1 year.
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
• Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms
• Signed informed consent form (ICF) .

Exclusion Criteria:

• Metastatic disease (Stage IV) ;
• Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
• Progressive disease during neoadjuvant therapy;
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
• Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
• Less than 4 weeks from the last clinical trial;
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
• Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pyrotinib; pyrotinib 400 mg, orally once daily for one year	Drug: pyrotinib; pyrotinib 400 mg, orally once daily for one year
No Intervention: No Pyrotinib; Observation follow-up

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.	From randomization until time of event up to 2 years

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jinsong Lu, Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: February 1, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 18, 2023
• Last Verified: November 1, 2023

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: KY2019-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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