a study to evaluate gemcitabine plus cisplatin in the treatment of tnbc patients following neoadjuvant chemotherapy

Conditions: Triple Negative Breast Cancer

Summary: this is a prospective, open-lable phase ii clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pcr tnbc patients after standard neoadjuvant chemotherapy.

this is a prospective, open-lable phase ii clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pcr tnbc patients after standard neoadjuvant chemotherapy. non-pcr tnbc patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of gp regimen chemotherapy(cisplatin 75 mg/m² d1 and gemcitabine 1250 mg/m² d1,8, every 3 weeks). our primary endpoint is disease free survival (dfs). secondary end points include overall survival (os), recurrence free survival (rfs), distant disease free survival (ddfs)rates and safety.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old * patients with histologically confirmed unilateral invasive ductal carcinoma(according to who histologically type) * tumor clinical staged as iib-iiib before neoadjuvant chemotherapy (according to the 7th ajcc edition). * after standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pcr (mp class 1-4) or lymph nodes are still positive for patients. * no gross or microscopic tumor residual after resection. * patients with clear er/pr/her2 receptor, and er/pr/her2 are all negative(specific definition: immunohistochemical detection of er \< 1% positive tumor cell is defined as the er negative, pr \< 1% positive tumor cells is defined as the pr negative, her2 0-1 or her2 2 + but after fish or cish tested negatie for c (no amplification) is defined as the her2-negative). * no evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is m0. * patients without peripheral neuropathy or i peripheral neurotoxicity. * eastern cooperative oncology group (ecog) performance status (ps) ≤1. * patients recovered well after surgery, at least 1 weeks after the operation. * adequate marrow: white blood cells count≥3000/μl,neutrophil count ≥1500/μl, hemoglobin ≥9g/dl and platelet count ≥75000/μl. * normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) ≤ 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln, and bilirubin ≤ 1.5uln. * adequate renal function: serum creatinine ≤ 1.5uln. * contraception during the treatment of child-bearing women. * adequate cardiac function :left ventricular ejection fraction (lvef) \> 50%. * patients must be informed of the investigational nature of this study and give written informed consent. * patients without serious heart, lung, liver, kidney and other important organs disease history. * patients have good compliance. exclusion criteria: * patients with bilateral breast cancer or carcinoma in situ(dcis/lcis). * metastasis of any part except axillary lymph nodes. * clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy. * there have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer. * patients have been enrolled in other clinical trials. * patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study. * patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension \>160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization. * pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.) * child-bearing women who are unwilling to take effective contraceptive measures in the course of research. * patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial). * persons without personal freedom and independent civil capacity.

Keywords: gemcitabine cisplatin non-pcr tnbc