Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer (CORIN-PYRA)

Wenjin Yin

Status and phase: Enrolling; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Drug: Pyrotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07180082

LY2025-118-A

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
• ECOG 0-1
• Adequate organ function

Exclusion criteria

• During pregnancy and lactation
• Difficulties with pyrotinib administration or absorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Intermittent pyrotinib

Experimental group

Description:

Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days

Treatment:

Drug: Pyrotinib

Continuous pyroitnib

Active Comparator group

Description:

oral pyrotinib qd

Treatment:

Drug: Pyrotinib