ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

NCT04172259 | Active Not Recruiting Phase 2

• 2 other identifiers: METISSCBCG-023
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy. We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.

Conditions

Breast Cancer; Neoadjuvant Chemotherapy

Keywords

Human epidermal growth factor receptor 2; Pathology complete response

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response rate (pCR)

  Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.

  At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Secondary Outcomes (6)

• Objective response rate (ORR)

  Approximately 20-24 weeks from first dose of study drug

• Event Free Survival (EFS)

  Up to 5 years from the date of definitive surgery

• Overall Survival (OS)

  Up to 5 years from the date of definitive surgery.

• Incidence of chemotherapy-induced cardiotoxicity

  Approximately 20-24 weeks from first dose of study drug

• Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

  First day of treatment (Day 1) up to 6 months during the post-surgery follow-up period (approximately 15 months from first dose of study drug)

Study Arms (2)

ACHP-THP

EXPERIMENTAL

Doxorubicin liposome（PLD）35 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week

Drug: Doxorubicin liposome; Drug: Cyclophosphamide; Drug: Trastuzumab; Drug: Docetaxel; Drug: Pertuzumab; Drug: Paclitaxel-albumin

EC-THP

ACTIVE COMPARATOR

Epirubicin（EPI）90 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week

Drug: Cyclophosphamide; Drug: Trastuzumab; Drug: Docetaxel; Drug: Epirubicin; Drug: Pertuzumab; Drug: Paclitaxel; Drug: Paclitaxel-albumin

Interventions

Doxorubicin liposome DRUG

PLD

Also known as: PLD

ACHP-THP

Cyclophosphamide DRUG

CTX

Also known as: CTX

ACHP-THP; EC-THP

Trastuzumab DRUG

H

Also known as: Herceptin

ACHP-THP; EC-THP

Docetaxel DRUG

DOC

Also known as: Taxotere

ACHP-THP; EC-THP

Epirubicin DRUG

EPI

Also known as: EPI

EC-THP

Pertuzumab DRUG

P

ACHP-THP; EC-THP

Paclitaxel DRUG

paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week

EC-THP

Paclitaxel-albumin DRUG

albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week

ACHP-THP; EC-THP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, \>/= 18 years of age, \</= 70 years of age.
• HER2-positive breast cancer
• Histologically confirmed invasive breast carcinoma
• Clinical stage T2-4/N0-3/M0 or node positive at presentation (patients with T1 tumors will not be eligible)
• Known hormone-receptor status
• Non previous anti-breast cancer neoadjuvant chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hematologic, renal and liver function
• Screening Left ventricular ejection fraction (LVEF) \>/= 50% on echocardiogram (ECHO)
• Adequate organ function

You may not qualify if:

• Stage IV (metastatic) breast cancer or bilateral breast cancer
• History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ)
• History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
• Cardiopulmonary dysfunction as defined by protocol
• Current severe, uncontrolled systemic disease
• Pregnant or lactating women
• Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
• Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
• History of intolerance, including Grade 3 to 4 infusion reaction or
• hypersensitivity to trastuzumab or chemotherapy drugs

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (20)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; 1-dodecylpyridoxal; Cyclophosphamide; Trastuzumab; Docetaxel; Epirubicin; pertuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wen Xia, MD

  SunYat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: November 21, 2019
• Study Start: January 10, 2019
• Primary Completion: September 30, 2023
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

CN (1)