Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

NCT00379015 | Completed Phase 2

• 2 other identifiers: CDR0000496448TUSM-BRI-BC04-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB, stage IIIC, or stage IV primary breast cancer.

Conditions

Breast Cancer

Keywords

stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Pathological complete response is assessed in surgical resected specimens of primary tumor from patients who underwent a primary radical surgery in this study.

  Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab

Secondary Outcomes (5)

• Clinical response

  From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery.

• Pathological response of axillary lymph nodes

  Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab.

• Recurrence-free survival

  8 years

• Overall survival

  8 years

• Adverse event

  70 months

Study Arms (1)

HER2 over-expressing primary breast cancer group

EXPERIMENTAL

Patients receive epirubicin hydrochloride and cyclophosphamide in week 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses. Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.

Biological: trastuzumab; Drug: cyclophosphamide; Drug: docetaxel; Drug: epirubicin hydrochloride; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

trastuzumab BIOLOGICAL

HER2 over-expressing primary breast cancer group

cyclophosphamide DRUG

HER2 over-expressing primary breast cancer group

docetaxel DRUG

HER2 over-expressing primary breast cancer group

epirubicin hydrochloride DRUG

HER2 over-expressing primary breast cancer group

conventional surgery PROCEDURE

HER2 over-expressing primary breast cancer group

neoadjuvant therapy PROCEDURE

HER2 over-expressing primary breast cancer group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of primary breast cancer * Stage IIIB, IIIC, or IV disease * No inflammatory disease * HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization * Hormone receptor status known PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Performance status 0-1 * WBC ≤ 10,000/mm³ * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.5 g/dL * SGOT/SGPT ≤ 60 IU/L * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * LVEF ≥ 55% * No signs of pneumonitis PRIOR CONCURRENT THERAPY: * No prior surgery except for biopsy * No prior or concurrent chemotherapy and/or hormonal therapy * No prior or concurrent biological therapy * No prior or concurrent radiotherapy except postoperative radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead

Study Sites (5)

Shikoku Cancer Center

Matsuyama, Ehime, 791-0288, Japan

Location

National Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Keio University Hospital

Tokyo, Tokyo, 160-8582, Japan

Location

Teikyo University School of Medicine

Tokyo, Tokyo, 173-8605, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Cyclophosphamide; Docetaxel; Epirubicin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tadashi Ikeda, MD

  Teikyo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

JP (5)