EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

NCT05883852 | Recruiting Phase 3

• 1 other identifier: SCHBCC-N055
• Study Type: interventional
• Target: 1,406
• Locations: 1 country
• Sites: 1

Brief Summary

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

Conditions

HER2 Positive Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• iDFS

  invasive Disease Free Survival

  5 years

Secondary Outcomes (3)

• DRFS

  5 years

• OS

  5 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 1 year

Study Arms (2)

Arm A：TCbHP

EXPERIMENTAL

Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.

Drug: Docetaxel; Drug: carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

Arm B：EC-THP

ACTIVE COMPARATOR

Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.

Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Epirubicin; Drug: cyclophosphamide

Interventions

Docetaxel DRUG

Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer

Arm A：TCbHP; Arm B：EC-THP

carboplatin DRUG

Carboplatin is a DNA synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.

Arm A：TCbHP

Trastuzumab DRUG

Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,

Arm A：TCbHP; Arm B：EC-THP

Pertuzumab DRUG

Pertuzumab is a recombinant humanized monoclonal antibody that specifically binds to the extracellular dimerization domain (subdomain Ⅱ) of epidermal growth factor receptor 2(HER2).

Arm A：TCbHP; Arm B：EC-THP

Epirubicin DRUG

Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.

Arm B：EC-THP

cyclophosphamide DRUG

An anticancer (antitumor or cytotoxic) chemotherapy drug that is classified as an alkylating agent. Alkylating agents are compounds that prevent the normal connection of the double helix chain by adding an alkyl group to the guanine base of the DNA molecule. It causes breaks in DNA strands, affecting the ability of cancer cells to proliferate.

Arm B：EC-THP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70；
• 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。

You may not qualify if:

• 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；

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; Carboplatin; Trastuzumab; pertuzumab; Epirubicin; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: June 1, 2023
• Study Start: June 7, 2023
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)