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

Recruiting Phase 3 Interventional Study
Breast Cancer Invasive
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
488 (estimated)
Sponsor
RenJi Hospital · Other
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About This Trial

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.

Trial Locations
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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: * Met…
Contacts

Wenjin Yin, M.D.

86(21)58852345

yinwenjin@renji.com

CONTACT

Qi Lu

86(21)68383364

rjllb3364@163.com

CONTACT