ctDNA in HER2+ EBC Neoadjuvant Treatment
Recruiting · NCT07335081 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
- No prior treatment
Exclusion criteria
- Bilateral or metastatic breast cancer
- History of other malignancies
- Severe cardiovascular disease
- Allergic to any of the regimens
Where it is running
1 location listed.
- Ruijin Hospital - Shanghai, China