Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women Who Are Undergoing Surgery for Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00070278
• Other study ID #: CRUK-neo-tAnGo
• Secondary ID: CDR0000331863EU-
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 3, 2003
• Last updated: August 6, 2013
• Start date: January 2005

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating women who are undergoing surgery for early invasive breast cancer.

Description:

OBJECTIVES:

Primary

• Compare the complete pathological response rate in women with poor-risk early breast cancer treated with neoadjuvant sequential epirubicin, cyclophosphamide, and paclitaxel with vs without gemcitabine.

Secondary

• Compare the disease-free and overall survival of patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare the effect of these regimens on prognostic factors in these patients.

• Correlate molecular profiles, specific gene mutations, and genomic and gene expression changes with clinical outcome in these patients.

• Compare the quality of life of patients treated with these regimens.

• Determine the health economics associated with this study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen-receptor status (negative vs greater than 10% positive cells), HER-2 status (positive vs negative), tumor size (30-50 mm vs greater than 50 mm), and clinical involvement of axillary nodes (yes vs no). Patients are randomized to 1 of 4 treatment arms.

• Neoadjuvant sequential chemotherapy:

• Arm I: Patients receive epirubicin IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses.

• Arm II: Patients receive paclitaxel as in arm I followed by epirubicin and cyclophosphamide as in arm I.

• Arm III: Patients receive epirubicin and cyclophosphamide as in arm I followed by paclitaxel as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses.

• Arm IV: Patients receive paclitaxel as in arm I and gemcitabine as in arm III followed by epirubicin and cyclophosphamide as in arm I.

• Surgery: After completion of neoadjuvant chemotherapy, patients in all arms undergo definitive surgery.

Tumor tissue is removed from a subset of patients during serial biopsies. Molecular and genetic profiling, mutation analysis, and comparative genomic analysis is performed on the tissue samples.

Quality of life is assessed at baseline, after 4 courses of chemotherapy, after the completion of chemotherapy, after surgery, and then every 6 months for 2 years.

Patients are followed every 2 months for 2 years and then every 3 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 800 patients (200 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Grade 2 or 3

• Tumor size at least 3 cm by ultrasound

• No evidence of metastatic disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• Not specified

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Fit to receive study chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• epirubicin hydrochloride

• gemcitabine hydrochloride

• paclitaxel

Genetic:
• comparative genomic hybridization

• microarray analysis

• mutation analysis

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathological response after 4 courses			No
Secondary	Survival			No
Secondary	Disease-free survival			No
Secondary	Effect of prognostic factors			No