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
Study ID
NCT04296162
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine chemotherapy (oral)
  • Capecitabine — DRUG
    Capecitabine chemotherapy (oral)
  • Trastuzumab — DRUG
    Trastuzumab target therapy

Study Details

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

Key Dates

Start date
Mar 10, 2020
Status verified
May 2026
Primary completion
Apr 25, 2026
Completion
Apr 25, 2026

Study Design

Enrollment
182 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

disease free survival [ Time Frame: 5 year ]

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