To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and has adopted in early breast cancer treatment. A meta-analysis showed no difference between neoadjuvant therapy and adjuvant therapy in terms of survival and overall disease progression. Therefore, neoadjuvant treatment can be offered as a standard treatment and as an alternative to adjuvant treatment to all patients who are expected to be candidates for adjuvant systemic chemotherapy. Patients achieved pCR after treatment have superior outcome. The taxanes were introduced into clinical practice in the early 1990s, and recent meta-analysis showed that compared with anthracycline-containing chemotherapy, taxanes-containing regimens significantly reduced the annual breast cancer recurrences and deaths. Right now, TAC regimen has widely accepted as adjuvant or neoadjuvant chemotherapy regimens in breast cancer treatment. Metformin, an inexpensive oral agent commonly used to treat type 2 diabetes, has been garnering increasing attention as a potential anti-cancer agent. In neoadjuvant treatment of breast cancer, a retrospective clinical study from MDACC reported a significantly increased pCR rates to standard neoadjuvant chemotherapy in diabetic breast cancer patients who were receiving metformin (24% pCR) compared to diabetics not receiving metformin (8% pCR), with intermediate rates in non-diabetics who did not receive metformin (16% pCR), indicating metformin may increase pCR rate with neoadjuvant chemotherapy. Base on these data, we initiate a prospective study to evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. Our aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Metformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
Linyi People's Hospital
Linyi, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
pathologic complete response rate
To compare pathologic complete response (pCR) rate to neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer. Definition of pCR is no invasive tumor in primary breast and axillary lymph node.
Time frame: 5 months
Clinical response rate
To compare the clinical response rate between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer neoadjuvant treatment.
Time frame: up to 4.5 months
safety profile
To compare the tolerability and side effects of neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer treatment.
Time frame: up to 4.5 months
breast conservation therapy (BCT) rate
Time frame: 5 months
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500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.