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)

Breast Cancer Clinical Trial

— ORCHID  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296162
• Other study ID #: 1503144-7
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2020
• Source: Fudan University
• Contact: Zhi-Ming Shao
• Phone: 86-021-64175590
• Email: zhiimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. women aged 18-70 years old;

2. T =1cm and negative lymph node confirmed by histopathology after early breast cancer surgery

3. 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.)

4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

5. 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).

6. 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:

1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy);

2. Has bilateral breast cancer;

3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.

4. Has metastic (Stage 4) breast cancer;

5. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;

6. Patients participating in other clinical trials at the same time;

7. 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;

8. Has severe or uncontrolled infection;

9. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;

10. the researchers judged patients to be unsuitable for the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vinorelbine
Vinorelbine chemotherapy (oral)
• Capecitabine
Capecitabine chemotherapy (oral)
• Trastuzumab
Trastuzumab target therapy

Locations

Country	Name	City	State
China	Zhi-Ming Shao	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		5 year
Secondary	distant disease free survival		5 year
Secondary	overall survival		5 year