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Clinical Trial NCT04254263 (ATP) for Locally Advanced Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (ATP) Phase 3 316 No Placebo Placebo-Controlled Open-Label

Recruiting
Clinical Trial NCT04254263 (ATP) is designed to study Treatment for Locally Advanced Breast Cancer. It is a Phase 3 interventional study that is recruiting, having started on 16 December 2019, with plans to enroll 316 participants. Led by RenJi Hospital, it is expected to complete by 1 August 2028. The latest data from ClinicalTrials.gov was last updated on 11 September 2025.
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...Show More
Official Title

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

Conditions
Locally Advanced Breast Cancer
Other Study IDs
  • ATP
  • KY2019-070
NCT ID Number
NCT04254263
Start Date (Actual)
2019-12-16
Last Update Posted
2025-09-11
Completion Date (Estimated)
2028-08
Enrollment (Estimated)
316
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPyrotinib
pyrotinib 400 mg, orally once daily for one year
pyrotinib
pyrotinib 400 mg, orally once daily for one year
No InterventionNo Pyrotinib
Observation follow-up
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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) .

  • 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.
RenJi Hospital logoRenJi Hospital
Study Responsible Party
Wenjin Yin, Principal Investigator, Deputy Chief of Breast Surgery Department, RenJi Hospital
Study Central Contact
Contact: Wenjin Yin, 86(21)68385569, [email protected]
Contact: Qi Lu, 86(21)68383364, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200127, China
Jinsong Lu, MD, Contact, [email protected]
Recruiting