NX in Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy

NCT ID: NCT04307147

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2021-09-01

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

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

Vinorelbine

Intervention Type: DRUG

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

Control group

Standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Capecitabine

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

Intervention Type: DRUG

Vinorelbine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhimin Shao, MD

Role: primary

drzhimingshao@outlook.com

862164175590 ext. 88703

Lei Fan, MD

Role: backup

drfanlei@gmail.com

862164175590 ext. 88703

Other Identifiers

Fudan University

Identifier Type: -

Identifier Source: org_study_id