Health TrialsbyHealthPanel

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWenjin Yin

About this trial

This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years old

Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery

Pathologically confirmed HER2+ at least once for either primary or metastatic lesion

Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician

Disqualifiers

During pregnancy and lactation

Difficulties with pyrotinib administration or absorption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pyrotinib

    Drug

    anti-HER2 tyrosine kinase inhibitor

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Intermittent pyrotinibExperimental treatment 1 intervention
Group B: Continuous pyroitnibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.

Time frame
From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

Time frame
From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
2

Adverse events

Adverse events during maintenance therapy 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.

Wenjin Yin

Lead sponsor

RenJi Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now