Clinical trial NCT05834764: Pyrotinib in Women With High-risk in Early Stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2023-04-28
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign the informed consent form；
2. Female or male patients, aged ≥ 18 years, and ≤75 years;
3. ECOG PS score: 0-1;
4. 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).
5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
7. Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer
2. 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.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets
6. History of gastrointestinal disease with diarrhea as the major symptom.

Primary outcomes:
measure: Invasive Disease-free Survival (iDFS) at year 2
timeFrame: From enrollment until time of events up to 2 years
Secondary outcomes:
measure: Disease-free Survival at year 2 (2y-DFS)
timeFrame: From enrollment until time of events up to 2 years
measure: Overall Survival (OS)
timeFrame: Enrollment until death due to any cause, up to 10 years
measure: Invasive Disease-free Survival (iDFS) at year 5
timeFrame: From enrollment until time of events up to 5 years
measure: AEs and SAEs
timeFrame: From the first administration to one months after the last drug administration
Other outcomes:
Locations:
city: Nanjing
country: China
facility: JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
name: Xiaoan Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References: