Triple Negative Breast Cancer
Conditions
Keywords
gemcitabine, cisplatin, non-pCR, TNBC
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.
Interventions
DRUGGemcitabine
Gemcitabine 1250mg/m2,d1,d8,every 3 weeks
DRUGCisplatin
Cisplatin 75mg/m2,d1，every 3 weeks
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
| Recurrence free survival | 3-year | Recurrence free survival is calculated from surgery to the first recurrence. |
| 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 | 3-year | Distant disease free survival is calculated from surgery to the first distant metastasis. |
| 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. |
Countries
China
Outcome results
None listed