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Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer

NCT05561686 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-09-30

No results posted yet for this study

Summary

Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.

Conditions

Interventions

DRUG

Pyrotinib

This study adopted a prospective, multicenter, observational design. From October 1, 2022, 100 patients with HER2-positive breast cancer scheduled to receive neoadjuvant therapy with pyrotinib were enrolled. The treatment regimen was determined according to the patient 's condition, physician' s treatment experience, evidence-based evidence and other factors to assess the clinical benefit (pCR, ORR) and safety of different neoadjuvant therapy modalities containing pyrotinib. Exploratory analysis was performed to investigate the correlation between the level of TMB and the pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib on intestinal flora.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Ying He, M.D. · Hunan Cancer Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561686 on ClinicalTrials.gov