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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Gemcitabine

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.