Overview

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

Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
Female
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Capecitabine
Trastuzumab
Vinorelbine
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 (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.