Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

NCT07180082 | Recruiting Phase 2 DMC

• 1 other identifier: LY2025-118-A
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

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.

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

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  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)

• Adverse events

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

Study Arms (2)

Intermittent pyrotinib

EXPERIMENTAL

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

Drug: Pyrotinib

Continuous pyroitnib

ACTIVE COMPARATOR

oral pyrotinib qd

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

anti-HER2 tyrosine kinase inhibitor

Continuous pyroitnib; Intermittent pyrotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Yin

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)