Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
Recruiting
Phase 2
Interventional Study
HER2-positive Early 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
- 200 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 and ≤75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
3. Primary tumor size \>1 cm.
4. Histologically confirmed invasive breast cancer, clinically staged as:
* Stage I (T1cN0M0)
* Stage II (T1cN1M0, T2N0-1M0 or T3N0M0)
* Stage I…