Pyrotinib in Women With High-risk in Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pyrotinib.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
Overview
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
Interventions
- Drug Pyrotinib
Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）
Primary outcome measures
- Invasive Disease-free Survival (iDFS) at year 2 [Time frame: From enrollment until time of events up to 2 years]
Secondary outcome measures (4)
- Disease-free Survival at year 2 (2y-DFS) [Time frame: From enrollment until time of events up to 2 years]
- Overall Survival (OS) [Time frame: Enrollment until death due to any cause, up to 10 years]
- Invasive Disease-free Survival (iDFS) at year 5 [Time frame: From enrollment until time of events up to 5 years]
- AEs and SAEs [Time frame: From the first administration to one months after the last drug administration]
Eligibility criteria
Inclusion criteria
- Subjects voluntarily participate in this study and sign the informed consent form；
- Female or male patients, aged ≥ 18 years, and ≤75 years;
- ECOG PS score: 0-1;
- Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
- Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
- Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
- Could have been treated neoadjuvantly but have not reached pathologic complete response.
Exclusion criteria
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT05834764 · OBU-BC-II-083