Status:
UNKNOWN
NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 cance...
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 cance...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04307147
Start Date
July 3 2018
End Date
September 1 2021
Last Update
March 13 2020
Active Locations (1)
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1
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032