A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP group<br>Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks). | Drug: Gemcitabine<br>* Gemcitabine 1250mg/m2,d1,d8,every 3 weeks<br>Drug: Cisplatin<br>* Cisplatin 75mg/m2,d1，every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | Recurrence free survival is calculated from surgery to the first recurrence. | 3-year | 
| Distant disease free survival | Distant disease free survival is calculated from surgery to the first distant metastasis. | 3-year | 
| Overall survival | Overall survival is calculated from randomization to death from any cause. | 3-year | 
| Disease free survival(5year) | The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer | 5-year | 
| Recurrence free survival(5year) | Recurrence free survival(5y) is calculated from surgery to the first recurrence. | 5-year | 
| Distant disease free survival(5year) | Distant disease free survival is calculated from surgery to the first distant metastasis. | 5-year | 
| Overall survival(5year) | Overall survival is calculated from randomization to death from any cause. | 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gemcitabine, cisplatin, non-pCR, TNBC