This is a prospective, randomized and open-label phase II study, evaluating the efficacy and safety of AT vs TP regimen as neoadjuvant treatment for early HER2-negative breast cancer. Participants will undergo/receive HRD testing after enrollment. HRD-positive patients will be randomly assigned in a ratio of 1:1 to receive AT(Doxorubicin or Epirubicin+docetaxel)or TP(Albumin paclitaxel + Cisplatin or Carboplatin)regimen respectively, followed by surgery. HRD-negative patients will be assigned to receive TP(Albumin paclitaxel + Cisplatin or Carboplatin)regimen if TNBC, or AT(Doxorubicin or Epirubicin+docetaxel)rigemen, followed by surgery.
This study intends to adopt Simon's two-stage optimal design. In stage 1, 15 HRD-positive and 15 HRD-negative patients will be recruited to receive AT or TP regimen as neoadjuvant therapy. If more than 5 patients in the HRD-positive group achieve pCR(pathological complete response) , the trial expands to stage 2, otherwise the trial terminates. In stage 2, another 31 HRD- positive and 31 HRD-negative patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 Docetaxel 75mg/㎡ d1 1/21d
Albumin paclitaxel 125mg/㎡ d1, 8 Cisplatin 75mg/㎡ d1-3 1/21d✖6 or carboplatin AUC6 d1 1/21d✖6
Department of breast surgery, Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Complete pathological response of breast and lymph nodes (ypT0/is ypN0; defined as no microscopic evidence of residual invasive viable tumor cells in all resected specimens of the breast and axilla)
1. To compare the pathologic response to neoadjuvant AT regimen in HER2- breast cancer with and without HR-deficiency, defined as a high HRD score or a BRCA mutation 2. To compare the pathologic response to neoadjuvant TP regimen in HER2- breast cancer with and without HR-deficiency, defined as a high HRD score or a BRCA mutation 3. To compare the pathologic response to neoadjuvant AT vs TP regimen in HER2- breast cancer with HR-deficiency, defined as a high HRD score or a BRCA mutation
Time frame: 24 weeks
Imaging response
To determine the response rates of the breast tumor and axillary nodes based on imaging tests. (sonography, mammography, or MRI) after treatment.
Time frame: 24 weeks
Residual cancer burden in patients with HRD
RCB in the breast tissue and the lymph node tissue will be performed after the completion of neoadjuvant systemic therapy.
Time frame: up to 24 weeks
response by pCR in HRD high versus tBRCA
To assess the pCR rate in HRD high with vs without tBRCA mutation
Time frame: 24 weeks
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