Breast Cancer
Conditions
Keywords
Breast cancer, Neoadjuvant therapy, HER2 positive, ctDNA
Brief summary
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
Interventions
DRUGpyrotinib
pyrotinib 320mg p.o. qd
DRUGpertuzumab
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
DRUGtrastuzumab
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
DRUGdocetaxel
docetaxel ivgtt q3w, 80-100mg/m2
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA clearance after one cycle neoadjuvant treatment | 3 months after neoadjuvant treatment initation | The rate of ctDNA clearance after first cycle of neoadjuvant treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA clearance after two cycle neoadjuvant treatment | 3 months after neoadjuvant treatment initation | The rate of ctDNA clearance after first two cycles of neoadjuvant treatments |
| pCR rate | 6 months after neoadjuvant treatment initation | 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 |
| bpCR rate | 6 months after neoadjuvant treatment initation | After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples |
| ORR | 6 months after neoadjuvant treatment initation | 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%). |
| EFS | 2 years after surgery | The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause |
| DFS | 2 years after surgery | The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause. |
| OS | 5 years after surgery | Time interval from randomization to death from any cause. |
Countries
China
Contacts
CONTACTHaoyu Wang
Outcome results
None listed