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CompletedNCT04296162ORCHIDUpdated May 26, 2026

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)

A Phase 2 interventional study of Vinorelbine and Capecitabine in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
182
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
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Study 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

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Conditions studied

  • Breast Cancer

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Keywords

  • oral vinorelbine
  • capecitabine
  • trastuzumab
  • adjuvant treatment
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 182 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
182 participants (actual)

Study arms

  • 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 · Drug: Capecitabine · Drug: Trastuzumab

Interventions

  • DrugVinorelbine

    Vinorelbine chemotherapy (oral)

  • DrugCapecitabine

    Capecitabine chemotherapy (oral)

  • DrugTrastuzumab

    Trastuzumab target therapy

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What researchers measure

Primary outcomes

  1. disease free survival

    Time frame: 5 year

Secondary outcomes

  1. distant disease free survival

    Time frame: 5 year

  2. overall survival

    Time frame: 5 year

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Study locations

1 site
  • Zhi-Ming Shao
    Shanghai, 200032, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04296162
Lead sponsor
Fudan University
Responsible party
Zhimin Shao (professor, Fudan University) — Principal investigator
First posted
Mar 5, 2020
Start date
Mar 10, 2020
Primary completion
Apr 25, 2026
Completion
Apr 25, 2026
Last update
May 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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