Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2028-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab and Pertuzumab

NCT04255056

Breast Cancer

UNKNOWN PHASE2

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

NCT05910398

Breast Cancer Invasive

RECRUITING PHASE3

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

NCT03980054

Breast Cancer

UNKNOWN PHASE3

Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

NCT05165225

Breast Cancer HER2-low-expressing Breast Cancer Hormone Receptor-positive Breast Cancer +1 more

ACTIVE_NOT_RECRUITING PHASE2

Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer

NCT05880927

Breast Cancer

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pyrotinib

pyrotinib 400 mg, orally once daily for one year

Group Type EXPERIMENTAL

pyrotinib

Intervention Type DRUG

pyrotinib 400 mg, orally once daily for one year

No Pyrotinib

Observation follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pyrotinib

pyrotinib 400 mg, orally once daily for one year

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No