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Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

ConditionLocally Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • pyrotinib

    Drug

    pyrotinib 400 mg, orally once daily for one year

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: PyrotinibExperimental treatment 1 intervention
Group B: No PyrotinibNo intervention 0 interventions

Trial outcomes

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.

Time frame
From randomization until time of event up to 2 years.

Secondary outcomes

1

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

Time frame
From randomization until time of event up to 2 years
2

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From randomization until time of event up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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