NCT05883852 EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
| NCT ID | NCT05883852 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | HER2 Positive Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,406 participants |
| Start Date | 2023-06-07 |
| Primary Completion | 2031-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,406 participants in total. It began in 2023-06-07 with a primary completion date of 2031-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
Eligibility Criteria
Inclusion Criteria: * Women aged 18-70； * 0-1 for ECOG； * Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)； * No gross or microscopic tumor remains after surgical resection； * Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive； * Postoperative pathological stage pT1-4N1-3M0； * Did not receive neoadjuvant chemotherapy in the past； * The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery； * No peripheral neuropathy； * Good postoperative recovery, at least 1 week interval between operation； * The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN； * Contraception during treatment for women of reproductive age； * Cardiac function: LVEF\>50% for ultrasound examination； * The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。 Exclusion Criteria: * Bilateral breast cancer or carcinoma in situ DCIS/LCIS； * Have received chemotherapy for advanced disease； * Transfer of any part； * If any tumor \>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)； * Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy； * Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy； * Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years； * The patient has been enrolled in other clinical trials； * Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study； * LVEF\<50% (cardiac ultrasound)； * Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization； * Known allergy to related drugs； * Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment； * Pregnant and lactating women； * Those who tested positive for pregnancy before taking the drug after joining the trial； * Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)； * Persons without personal freedom and independent capacity for civil conduct。
Frequently Asked Questions
Who can join the NCT05883852 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HER2 Positive Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05883852 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,406 participants.
Is NCT05883852 currently recruiting?
Yes, NCT05883852 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT05883852 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05883852 clinical trial?
NCT05883852 is sponsored by Fudan University. The trial plans to enroll 1,406 participants.
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