Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT06992882

A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)

Led by Fudan University · Updated on 2025-07-18

2306

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Although there is a certain risk of recurrence of HER2-positive small tumors, the overall prognosis is relatively good. In order to further reduce the toxicity and side effects of treatment and explore the best strategy for adjuvant therapy in patients with HER2-positive stage IA breast cancer, we designed this phase III, randomized, open-label study to evaluate the efficacy and safety of paclitaxel plus trastuzumab and capecitabine versus paclitaxel plus trastuzumab in the adjuvant treatment of patients with HER2-positive, node-negative breast cancer.

CONDITIONS

Official Title

A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 70 years
  • Early breast cancer stage IA with tumor size no more than 2 cm and no lymph node involvement (pT1mic-T1cN0M0)
  • HER2 positive by immunohistochemistry or confirmed by FISH or CISH testing
  • Surgery to randomization interval no more than 8 weeks (56 days)
  • Normal blood counts: hemoglobin 6 g/L, ANC 1.5x10^9/L, platelets 100x10^9/L
  • Normal biochemistry: total bilirubin 1.5 times upper limit normal (ULN), ALT and AST 3 times ULN, serum creatinine 1 times ULN, creatinine clearance > 50 ml/min
  • Normal cardiac function: ECG normal, QTc < 470 ms, LVEF > 50%
  • Voluntary informed consent and ability to comply with study and follow-up
Not Eligible

You will not qualify if you...

  • Previous neoadjuvant chemotherapy, targeted therapy, radiotherapy, or endocrine therapy
  • History of other cancers except cured basal cell carcinoma or carcinoma in situ of cervix
  • Any metastasis
  • Pregnant or breastfeeding, or women unable to use effective contraception
  • Participation in other clinical trials
  • Severe organ dysfunction or cardiovascular disease including LVEF < 50%, unstable angina, heart failure, uncontrolled hypertension >150/90 mmHg, recent heart attack or stroke
  • Poorly controlled diabetes or severe hypertension
  • Severe or uncontrolled infections
  • History of drug abuse or mental disorders preventing study compliance
  • Investigator judgment deeming participant unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhimin Shao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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