A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy

A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy

This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhi-Ming Shao, M.D.; Phone Number: 862164175590 862164175590; Email: zhimingshao@yahoo.com
• Study Contact Backup: Name: Zhi-Min Shao; Email: zhimingshao@yahoo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Breast cancer institute of Fudan University Cancer Hospital
      • Contact: Zhi-Ming Shao, MD; Phone Number: 86-21-641755901105; Email: zhimingshao@yahoo.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 (at least 6 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs combined with trastuzumab), 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 Her2 receptor positive (Specific definition: immunohistochemical detection of Her2 3+ or Her2 2 + but after FISH or CISH tested is positive).
• 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NXH group; Patients should receive four cycles of NXH regimen (vinorelbine at 25 mg/m2 iv infusion on day 1 and day 8 plus capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle, trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year).	Drug: Vinorelbine; vinorelbine 25mg/m2 on day 1 and 8,every 3 weeks; Drug: Capecitabine; Capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle
No Intervention: H group; Patients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year.

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	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival	Recurrence free survival is calculated from surgery to the first recurrence	3 year
Distant disease free survival	Distant disease free survival is calculated from surgery to the first distant metastasis.	3 year
Overall survival	Overall survival is calculated from randomization to death from any cause.	5=3 year

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Zhi-Ming Shao, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2016
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: March 7, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: capecitabine; HER2 positive; vinorelbine; non-pCR
• Additional Relevant MeSH Terms: 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: FUSCC-162-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No