Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

Phase 3

Recruiting

• Conditions: Breast Cancer Invasive
• Interventions: Drug: pyrotinib

• Registration Number: NCT05910398
• Lead Sponsor: RenJi Hospital

Brief Summary

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Primary Completion: 2030-04
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• Aged ≥18 and ≤70 years;
• Histologically confirmed invasive HER2 positive breast cancer;
• Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
• Adequate organ functions.

Exclusion Criteria

• Metastatic disease (Stage IV);
• Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
• Treated or treating with anti-HER2 tyrosine kinase inhibitor;
• Less than 4 weeks from the last clinical trial;
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
• Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous pyrotinib	pyrotinib	pyrotinib 400 mg, orally once daily for one year
intermittent pyrotinib	pyrotinib	pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles

Primary Outcome Measures

Name	Time	Method
Invasive Disease-free Survival (iDFS)	From randomization until time of event up to 2 years.	Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	From randomization until time of event up to 2 years	Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause
Adverse events	From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)	Adverse events will be assessed according to the NCI CTCAE v5.0.
Overall Survival (OS)	From randomization until time of event up to 2 years	Overall survival is defined as the time from randomization to death from any cause.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China