A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
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
- 65 (estimated)
- Sponsor
- Shengjing Hospital · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Female patients aged ≥ 18 but ≤ 75 years
* Histologically confirmed to be HER2-positive invasive breast cancer
* Treatment-naive patients with stage II-III
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Good level of organ function
Exclusion Criteria:
* Previously r…
Contacts