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)

NCT ID: NCT04296162

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2027-06-30

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Vinorelbine chemotherapy (oral)

Capecitabine

Intervention Type: DRUG

Capecitabine chemotherapy (oral)

Trastuzumab

Intervention Type: DRUG

Trastuzumab target therapy

Interventions

Vinorelbine

Vinorelbine chemotherapy (oral)

Intervention Type: DRUG

Capecitabine

Capecitabine chemotherapy (oral)

Intervention Type: DRUG

Trastuzumab

Trastuzumab target therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• 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

Zhimin Shao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhi-Ming Shao

Shanghai, , China

Countries

China

Other Identifiers

1503144-7

Identifier Type: -

Identifier Source: org_study_id