A Phase 3 interventional study of Paclitaxel Cisplatin and fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T) in Triple Negative Breast Cancer, sponsored by Fudan University. Completed. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence.
According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients.
Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies.
The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.
Eligibility Female adults(18-70 years old) are eligible if they had histologically confirmed primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1, absolute neutrophil count (ANC)>1500/mm3,hemoglobin >90g/dL, and platelet count >100,000/mm3,creatinine\<2.5 times the upper limit of normal(ULN)）, transaminases\<3 times ULN or alkaline phosphatase\<4 times ULN if transaminases was normal, and total bilirubin \<1.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases.
This study protocol was approved by institutional ethic review boards and conducted according to guidelines for good clinical practice and the Helsinki Declaration.All patients provided written informed consent.
Outcome Measures Primary Endpoint：5 year Disease Free Survival（DFS） Second Endpoints：5 year distant disease free survival （DDFS） 5 year event free survival （EFS） 5 year overall survival （OS） 5 year DFS in gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 647 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,271 studies on the registry; 624 are open to participants now.
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Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):
Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER\<1%, PR\<1% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative].
Exclusion Criteria:
paclitaxel 80 mg/m2 and carboplatin (area under the curve \[AUC\]= 2) on day 1, 8, 15 every 28 days for six cycles
Drug: Paclitaxel Cisplatin
fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously
Drug: fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)
Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15 1 cycle = 28days PC\*6
fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously
disease-free survival
time from random assignment to first relapse (local, regional and distant), contralateral breast cancer
Time frame: 5 year
distant disease-free survival
time from random assignment to distant recurrence or death
Time frame: 5 year
relapse-free survival
time from the date of randomization to local, regional, distant relapse or death
Time frame: 5 year
disease-free survival gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers
Time frame: 5 year
overall survival
time from randomization until death with any cause
Time frame: 5 year
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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