NCT05910398 Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
| NCT ID | NCT05910398 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | RenJi Hospital |
| Condition | Breast Cancer Invasive |
| Study Type | INTERVENTIONAL |
| Enrollment | 488 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 488 participants in total. It began in 2023-06-01 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Aged ≥18; * 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.
Contact & Investigator
Wenjin Yin, M.D.
PRINCIPAL INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Frequently Asked Questions
Who can join the NCT05910398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Invasive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05910398 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 488 participants.
Is NCT05910398 currently recruiting?
Yes, NCT05910398 is actively recruiting participants. Contact the research team at yinwenjin@renji.com for enrollment information.
Where is the NCT05910398 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05910398 clinical trial?
NCT05910398 is sponsored by RenJi Hospital. The principal investigator is Wenjin Yin, M.D. at Renji Hospital, School of Medicine, Shanghai Jiao Tong University. The trial plans to enroll 488 participants.
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