CORINNE-PI: Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: continuous pyrotinib pyrotinib 400 mg, orally once daily for one year |
Drug: pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
|
| Experimental: intermittent pyrotinib pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles |
Drug: pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RenJi Hospital
Investigators
- Principal Investigator: Wenjin Yin, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LY2023-063-A