NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

Overview

This is a prospective, randomized, open-lable phase III clinical trial evaluating the effectiveness and safety of vinorelbine plus capecitabine as adjuvant treatment for non-pCR Luminal B breast cancer patients after standard neoadjuvant chemotherapy.

Full Title of Study: “Study Evaluating Vinorelbine Plus Capecitabine in the Treatment of Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2021

Detailed Description

This is a prospective ,randomized, open-lable phase III clinical trial evaluating the effectiveness and safety of vinorelbine plus capecitabine as adjuvant treatment for non-pCR Luminal B breast cancer patients after standard neoadjuvant chemotherapy. Non-pCR Luminal B patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of NX regimen chemotherapy for 4 cycles (vinorelbine 25 mg/m² d1,8 and capecitabine 1250 mg/m² d1-14, every 3 weeks) or not. the investigator's 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

  • Drug: Capecitabine
    • Oral capecitabine (at a dose of 1250 mg/m², twice per day, on days 1 to 14) every 3 weeks for 4 cycles.
  • Drug: Vinorelbine
    • Intravenous vinorelbine (at a dose of 25 mg/m² on day 1, day 8) every 3 weeks for 4 cycles.

Arms, Groups and Cohorts

  • Experimental: NX (vinorelbine and capecitabine )
    • Standard therapy plus NX chemotherapy for 4 cycles, (vinorelbine 25 mg/m² d1,8 and capecitabine 1250 mg/m² d1-14, every 3 weeks)
  • No Intervention: Control group
    • Standard therapy

Clinical Trial Outcome Measures

Primary Measures

  • Disease free survival
    • Time Frame: 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

Secondary Measures

  • Overall survival
    • Time Frame: 5-year
    • Overall survival is calculated from randomization to death from any cause.

Participating in This Clinical Trial

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. – Luminal B breast cancer defined as positive oestrogen and/or progesterone receptors, a negative HER2 defined as negative ISH test or an IHC status of 0 or 1+ as per local laboratory testing and a Ki67 > 14%. – 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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor

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