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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
pyrotinib
Drugpyrotinib 320mg p.o. qd
pertuzumab
Drugpertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab
Drugtrastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxel
Drugdocetaxel ivgtt q3w, 80-100mg/m2
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Pyrotinib-initiated armExperimental treatment 4 interventions
Group B: Pertuzumab-initiated armActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
ctDNA clearance after one cycle neoadjuvant treatment
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
Time frame
3 months after neoadjuvant treatment initationSecondary outcomes
1
ctDNA clearance after two cycle neoadjuvant treatment
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Time frame
3 months after neoadjuvant treatment initation2
pCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples
Time frame
6 months after neoadjuvant treatment initation3
bpCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Time frame
6 months after neoadjuvant treatment initation4
ORR
The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).
Time frame
6 months after neoadjuvant treatment initationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov