Clinical Trial: NCT04296162
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)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Fudan University |
| Information Provided By: | Fudan University |
| Last Update Posted: | 2026-05-26 |
Study Overview
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
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)
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Vinorelbine
- Drug: Capecitabine
- Drug: Trastuzumab
Other Study ID Numbers
- 1503144-7
Start Date (Actual)
2020-03-10
Primary Completion Date (Actual)
2026-04-25
Study Completion Date (Actual)
2026-04-25
Enrollment (Actual)
182
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Fudan University |
| Information Provided By: | Fudan University |
| Last Update Posted: | 2026-05-26 |
Study Overview
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
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)
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Vinorelbine
- Drug: Capecitabine
- Drug: Trastuzumab
Other Study ID Numbers
- 1503144-7
Start Date (Actual)
2020-03-10
Primary Completion Date (Actual)
2026-04-25
Study Completion Date (Actual)
2026-04-25
Enrollment (Actual)
182
Study Type
Interventional
Phase
Phase 2