Clinical trial NCT04297267: A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: gemcitabine
cisplatin
non-pCR
TNBC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease free survival
timeFrame: 3-year
Secondary outcomes:
measure: Recurrence free survival
timeFrame: 3-year
measure: Distant disease free survival
timeFrame: 3-year
measure: Overall survival
timeFrame: 3-year
measure: Disease free survival(5year)
timeFrame: 5-year
measure: Recurrence free survival(5year)
timeFrame: 5-year
measure: Distant disease free survival(5year)
timeFrame: 5-year
measure: Overall survival(5year)
timeFrame: 5-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital/ Institute, Fudan University
state: Shanghai
Study officials:
References: