NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

NCT04307147 | Unknown Phase 3

• 1 other identifier: Fudan University
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  5-year

Study Arms (2)

NX (vinorelbine and capecitabine )

EXPERIMENTAL

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; Drug: Vinorelbine

Control group

NO INTERVENTION

Standard therapy

Interventions

Capecitabine DRUG

Oral capecitabine (at a dose of 1250 mg/m², twice per day, on days 1 to 14) every 3 weeks for 4 cycles.

NX (vinorelbine and capecitabine )

Vinorelbine DRUG

Intravenous vinorelbine (at a dose of 25 mg/m² on day 1, day 8) every 3 weeks for 4 cycles.

NX (vinorelbine and capecitabine )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 13, 2020
• Study Start: July 3, 2018
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

CN (1)