ctDNA in HER2+ EBC Neoadjuvant Treatment
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Bilateral or metastatic breast cancer
History of other malignancies
Severe cardiovascular disease
Allergic to any of the regimens
Trial design
Treatments tested in this trial
- pyrotinib
- pertuzumab
- trastuzumab
- docetaxel
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov