A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy
- Registration Number
- NCT04297267
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GP group Cisplatin 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). GP group Gemcitabine 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).
- Primary Outcome Measures
Name Time Method Disease free survival 3-year The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
- Secondary Outcome Measures
Name Time Method Recurrence free survival 3-year Recurrence free survival is calculated from surgery to the first recurrence.
Distant disease free survival 3-year Distant disease free survival is calculated from surgery to the first distant metastasis.
Overall survival 3-year Overall survival is calculated from randomization to death from any cause.
Disease free survival(5year) 5-year The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Distant disease free survival(5year) 5-year Distant disease free survival is calculated from surgery to the first distant metastasis.
Overall survival(5year) 5-year Overall survival is calculated from randomization to death from any cause.
Recurrence free survival(5year) 5-year Recurrence free survival(5y) is calculated from surgery to the first recurrence.
Trial Locations
- Locations (1)
Cancer Hospital/ Institute, Fudan University
🇨🇳Shanghai, Shanghai, China