A Study Comparing the Efficacy of TCbHP and ECHP-THP in the Neoadjuvant Treatment of HER2-positive Breast Cancer

NCT05474690 | Withdrawn Phase 3 DMC

• 1 other identifier: HNCH-BC010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In 2020, the incidence of breast cancer surpassed that of lung cancer for the first time, becoming the number one cancer in the world. HER2 is an important prognostic indicator and therapeutic target for breast cancer. HER2-overexpressing breast cancer accounts for about 20% to 30% of all breast cancer patients. Targeted therapy for HER2 protein is the core treatment for this type of breast cancer. At present, the neoadjuvant treatment mode of trastuzumab and pertuzumab dual-target chemotherapy has become the standard neoadjuvant treatment for high-risk HER2-positive breast cancer. For patients with early-stage high-risk or locally advanced HER2-positive breast cancer, whether standard neoadjuvant regimen without anthracycline can achieve the same therapeutic effect compared with regimen containing anthracycline is still inconclusive.Therefore, this study aimed to compare the efficacy and safety of two neoadjuvant treatment regimens, TCbHP\*6 and ECHP\*4-THP\*4, in the neoadjuvant treatment of HER2-positive breast cancer through a randomized controlled phase 3 clinical trial.

Conditions

Breast Cancer; HER2-positive Breast Cancer

Keywords

Breast cancer; HER2; pathological complete remission

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Percentage of Participants With Pathological Complete Response (pCR) (ypT0/is/N0M0) after 6 cycles of neoadjuvant chemotherapy

  up to 24 weeks

Secondary Outcomes (5)

• Number of treatment-related adverse events assessed by CTCAE v4.0

  up to 24 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 24 weeks

• ORR

  up to 24 weeks

• DFS

  up to 60 months

• OS

  up to 120 months

Other Outcomes (1)

• gene mutation rate

  up to 24 weeks

Study Arms (2)

TCbHP chemotherapy regimen

ACTIVE COMPARATOR

Docetaxel + Carboplatin + Trastuzumab + Pertuzumab

Drug: Docetaxel + Carboplatin + Trastuzumab + Pertuzumab

ECHP-THP chemotherapy regimen

EXPERIMENTAL

(Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)

Drug: (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)

Interventions

Docetaxel + Carboplatin + Trastuzumab + Pertuzumab DRUG

Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1. Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative). TCbHP regimen drug dose: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + pertuzumab Antibiotics (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.

Also known as: TCbHP regimen group

TCbHP chemotherapy regimen

(Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) DRUG

Dosage of ECHP-THP regimen: epirubicin 90mg/m2+cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg /kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.

Also known as: ECHP-THP regimen group

ECHP-THP chemotherapy regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ age ≤ 65 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1；
• Clinical T2-T4d, or T1c with axillary LN+；
• HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization \[fish\] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital；
• Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization
• Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication： Absolute value of neutrophil count ≥ 2.0×10\^9 / L Hemoglobin ≥ 100g / L Platelet count ≥ 100×10\^9 / L Total bilirubin \< 1.5 ULN (upper limit of normal value) Creatinine \< 1.5 × ULN AST/ALT \< 1.5×ULN
• Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)；
• For women of childbearing age, serum pregnancy test was negative 14 days ；
• Signed the informed consent form prior to patient entry；

You may not qualify if:

• Stage IV (metastatic) breast cancer;
• supraclavicular lymph node metastasis；
• For this disease, chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. have been received;
• The patient has a second primary malignancy other than adequately treated skin cancer;
• The patient has undergone major surgical procedures not related to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
• The patient has severe heart disease or discomfort, including but not limited to the following:Diagnosed history of heart failure or systolic dysfunction (LVEF \< 50%)；High-risk uncontrolled arrhythmias；Angina pectoris requiring antianginal medication；Clinically significant heart valve disease；ECG showing transmural myocardial infarction；Poorly controlled high blood pressure；
• Because the patient has other serious and uncontrollable medical diseases, the investigator believes that chemotherapy is contraindicated;
• Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

Docetaxel; Carboplatin; Trastuzumab; pertuzumab; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: July 26, 2022
• Study Start: May 11, 2022
• Primary Completion: March 28, 2023
• Study Completion: August 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (1)