Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NCT04254263 | Recruiting Phase 3 DMC

• 1 other identifier: KY2019-070
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disease-free Survival (DFS)

  From randomization until time of event up to 2 years

• Overall Survival (OS)

  From randomization until time of event up to 2 years

Study Arms (2)

Pyrotinib

EXPERIMENTAL

pyrotinib 400 mg, orally once daily for one year

Drug: pyrotinib

No Pyrotinib

NO INTERVENTION

Observation follow-up

Interventions

pyrotinib DRUG

pyrotinib 400 mg, orally once daily for one year

Pyrotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

• Jinsong Lu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin

CONTACT

86(21)68385569; followroad@163.com

Qi Lu

CONTACT

86(21)68383364; rjllb3364@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 5, 2020
• Study Start: December 16, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)