Status:
RECRUITING
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)
Lead Sponsor:
Fudan University
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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 explor...
Eligibility Criteria
Inclusion
- Females aged 18\~70;
- The postoperative pathological stage of early breast cancer is stage IA: the longest diameter of invasive cancer is not more than 2cm and the lymph node is negative: pT1mic-T1cN0M0 (micro-invasion needs to meet multiple foci).
- Pathological immunohistochemistry must meet the following conditions: HER-2 (3) or HER-2 (0-2) but amplified by FISH or CISH testing.
- The maximum number of weeks (56 days) from surgery to randomization is not more than 8 weeks (56 days).
- The function of major organs is normal, that is, the following criteria are met: (1) The criteria for routine blood examination must meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L； PLT ≥100×109 /L； (2) Biochemical tests must meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \>50 ml/min (Cockcroft-Gault formula);
- Cardiac function: ECG was generally normal, QTc \< 470 ms, LVEF \>50%;
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up
Exclusion
- Patients who have received neoadjuvant therapy, including chemotherapy, targeted, radiotherapy, or endocrine therapy;
- History of other malignant tumors in the past, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- metastasis of any site;
- Pregnant or lactating women, women of childbearing age who cannot use effective contraception;
- Patients who are also participating in other clinical trials;
- Severe organ function (heart, lung, liver, kidney) insufficiency, LEVF \< 50% (ultrasound), severe cardiovascular and cerebrovascular diseases (such as: unstable angina, chronic heart failure, uncontrolled hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; Diabetic patients with poor glycemic control; Patients with severe hypertension;
- Severe or uncontrolled infection;
- Those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorder;
- Patients who are judged by the investigator to be unsuitable to participate in this study.
Key Trial Info
Start Date :
July 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2030
Estimated Enrollment :
2306 Patients enrolled
Trial Details
Trial ID
NCT06992882
Start Date
July 8 2025
End Date
June 10 2030
Last Update
July 18 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China, 200032