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NCT Number: NCT07180082

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin

CONTACT

[email protected]

86(21)68385569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyrotinib

Drug

anti-HER2 tyrosine kinase inhibitor

Primary outcomes

  1. Overall response rate (ORR)

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

    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.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    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)

    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.

  2. Adverse events

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Yin

CONTACT

Sponsors and collaborators

Lead sponsor

Wenjin Yin

Other

Registry information

Official study title

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial

Acronym: CORIN-PYRA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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