Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04296162

Collaborator

(none)

178

Enrollment

Location

Arm

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, open-lable Phase II clinical trial (ORCHID study) evaluating the effectiveness and safety of oral vinorelbine or capecitabine combined with trastuzumab as adjuvant treatment for patients with lymph node negative, HER-2 positive and small tumor size breast cancer

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Vinorelbine Drug: Capecitabine Drug: Trastuzumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm 6 cycle of oral vinorelbine or capecitabine combined with trastuzumab (21 days per cycle), followed by sequential single trastuzumab to 1 year	Drug: Vinorelbine Vinorelbine chemotherapy (oral) Drug: Capecitabine Capecitabine chemotherapy (oral) Drug: Trastuzumab Trastuzumab target therapy

Arm

Intervention/Treatment

Experimental: Single arm

6 cycle of oral vinorelbine or capecitabine combined with trastuzumab (21 days per cycle), followed by sequential single trastuzumab to 1 year

Drug: Vinorelbine

Vinorelbine chemotherapy (oral)

Drug: Capecitabine

Capecitabine chemotherapy (oral)

Drug: Trastuzumab

Trastuzumab target therapy

Outcome Measures

Primary Outcome Measures

disease free survival [5 year]

Secondary Outcome Measures

distant disease free survival [5 year]
overall survival [5 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women aged 18-70 years old;
T ≤1cm and negative lymph node confirmed by histopathology after early breast cancer surgery
HER2 positive confirmed by histopathology after early breast cancer surgery（HER2-positive breast cancer defined as a positive in situ hybridization test or an Immunohistochemistry (IHC) status of 3+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.)
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
Has bilateral breast cancer;
Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
Has metastic (Stage 4) breast cancer;
Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
Patients participating in other clinical trials at the same time;
Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
Has severe or uncontrolled infection;
Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
the researchers judged patients to be unsuitable for the study.