Pyrotinib in Women With High-risk in Early Stage Breast Cancer
Recruiting
Phase 2
Interventional Study
HER2-positive Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 188 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial
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 tra…
Trial Locations
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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 d…
Contacts