Clinical trial · Interventional
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
NCT04307147CI-TRIAL-00044001unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NX (vinorelbine and capecitabine )
- description
- Standard therapy plus NX chemotherapy for 4 cycles, (vinorelbine 25 mg/m² d1,8 and capecitabine 1250 mg/m² d1-14, every 3 weeks)
- interventionNames
- Drug: Capecitabine
- Drug: Vinorelbine
- type
- NO_INTERVENTION
- label
- Control group
- description
- Standard therapy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 5-year
- description
- The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.