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

ConditionBreast Cancer Invasive
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18;

Histologically confirmed invasive HER2 positive breast cancer;

Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;

Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;

Disqualifiers

Metastatic disease (Stage IV);

Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;

Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;

Treated or treating with anti-HER2 tyrosine kinase inhibitor;

Trial design

Design model

Parallel

Treatments tested in this trial

  • pyrotinib

    Drug

    an irreversible anti-HER2 tyrosine kinase inhibitor

Treatment groups

488 Participants
are divided into 2 treatment groups
Group A: continuous pyrotinibActive comparator 1 intervention
Group B: intermittent pyrotinibExperimental treatment 1 intervention

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
3

Adverse events

Adverse events will be assessed according to the NCI CTCAE v5.0.

Time frame
From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)

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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