NCT05834764 Pyrotinib in Women With High-risk in Early Stage Breast Cancer
| NCT ID | NCT05834764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2023-04-08 |
| Primary Completion | 2026-06-01 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 188 participants in total. It began in 2023-04-08 with a primary completion date of 2026-06-01.
⚠ 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
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.
Contact & Investigator
Xiaoan Liu, Professor
PRINCIPAL INVESTIGATOR
Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05834764 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying HER2-positive Breast Cancer. 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 NCT05834764 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05834764 currently recruiting?
Yes, NCT05834764 is actively recruiting participants. Contact the research team at liuxiaoan@126.com for enrollment information.
Where is the NCT05834764 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05834764 clinical trial?
NCT05834764 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Xiaoan Liu, Professor at Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University. The trial plans to enroll 188 participants.
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