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

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379015
• Other study ID #: CDR0000496448
• Secondary ID: TUSM-BRI-BC04-01
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2006
• Last updated: September 27, 2016
• Start date: January 2006
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Translational Research Informatics Center Ethical Committiee: Japan
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Determine the pathological complete response in women with HER2-positive stage IIIB-IV breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®).

Secondary

• Determine the clinical response in patients treated with this regimen.

• Determine the recurrence-free survival of patients treated with this regimen.

• Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• trastuzumab

Drug:
• cyclophosphamide

• docetaxel

• epirubicin hydrochloride

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
Japan	National Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Shikoku Cancer Center	Matsuyama-shi	Ehime
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Keio University Hospital	Tokyo
Japan	Teikyo University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical response	Clinical response is assessed as overall response in target lesion of primary tumor from 7 days after the last administration of neoadjuvant therapy of Trastuzumab until surgery.	From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery.	No
Secondary	Pathological response of axillary lymph nodes	Pathological response of axillary lymph nodes is assessed in surgical 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.	No
Secondary	Recurrence-free survival	Recurrence-free survival is defined as time from date of enrollment until date of recurrence or death from any cause, whichever comes first.	8 years	No
Secondary	Overall survival	Overall survival is defined as time from date of enrollment until date of death from any cause.	8 years	No
Secondary	Adverse event	Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.	70 months	Yes