This study is conducted in 50 subjects diagnosed with locally advanced breast cancer. Neoadjuvant chemotherapy in such tumors is basically used to reduce tumor size. The standard neoadjuvant regimen used, is the combination of doxorubicin, cyclophosphamide and paclitaxel. End point of neoadjuvant chemotherapy is reaching pathologic complete response (pCR). Generally regardless of the neoadjuvant regimen, pCR, considered as a prognostic factor for response to therapy, has been estimated to be 3-46% in different studies. Since pCR can be relevant to patients’ survival rate, efforts to increase this parameter can be beneficial for the patient. The aim of this study is to evaluate a second line neoadjuvant chemotherapy with the hope of increasing pCR in patients that have not reached a complete clinical response after the standard neoadjuvant regimen. Patient’s clinical status and sonography data are parameters used for evaluating clinical response. According to previous studies and data proving the effectiveness of other agents, carboplatin and gemcitabine with the estimated dose of AUC x 5 and 1g/m2 respectively have been selected as the second line regimen. Two to 3 cycles of second line therapy has been planned. Patients are randomly divided to control and intervention groups. The control group will be receiving the standard neoadjuvant chemotherapy and the intervention group will be treated with both standard and second line chemotherapy. The pathologist and statistical analyst will be blind towards studied groups of patients.
IRCTID: IRCT2017100136491N1
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Comparison of clinical, radiologic and pathologic response rates of neoadjuvant chemotherapy regimen containing doxorubicin and cyclophosphamide with paclitaxel and gemcitabine in locally advanced breast cancer
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Efficacy and Complications of Short Course versus Long Course Concurrent Chemo-radiotherapy followed by Consolidation Chemotherapy and Delayed Surgery among Patients with Rectal Cancer.
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Study of efficacy and safety of neoadjuvant chemotherapy with CAPOX regimen and neoadjuvant chemoradiation in complete pathologic responce in locally advanced rectal cancer
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A Phase III, randomized, two armed, parallel, triple-blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) plus Trastuzumab, Carboplatin and Docetaxel compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) plus Trastuzumab, Carboplatin and Docetaxel in neoadjuvant treatment of HER 2 positive Breast Cancer patients
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Assessment of efficacy of weekly paclitaxel as a neoadjuvant chemotherapy in advanced ovarian cancers
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Clinical trial to evaluate the resectability rate and tumor response to neoadjuvant chemo radiotherapy in patients with locally advanced proximal gastric cancer and esophagogastric cancer.
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The evaluation of pathologic complete response and clinical complete response in locally advanced rectal cancer who treated with total neoadjuvant therapy compared with standard treatment
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Determination of efficacy and safety of adding Oxaliplatin to neoadjuvant chemotherapy in locally advanced breast cancer patients
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The effect of neoadjuvant chemotherapy on increasing resectability in patients with locally-advanced gastric cancer
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Study of efficacy and safety of low-dose rate endorectal brachytherapy in patients with clinical stage T2N1 or T3-4N0-2 resectable low rectal cancer