NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

Study Evaluating Vinorelbine Plus Capecitabine in the Treatment of Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Vinorelbine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer Hospital/ Institute, Fudan University
      • Contact: Zhimin Shao, MD; Phone Number: 88703 862164175590; Email: drzhimingshao@outlook.com
      • Contact: Lei Fan, MD; Phone Number: 88703 862164175590; Email: drfanlei@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
NO_INTERVENTION: Control group; Standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer	5-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is calculated from randomization to death from any cause.	5-year

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2018
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (ACTUAL): March 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Vinorelbine
• Other Study ID Numbers: Fudan University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No