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Phase III Randomized Neoadjuvant Study of Sequential Epirubicin, Cyclophosphamide, and Paclitaxel With Versus Without Gemcitabine in Women With Poor-Risk Early Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Biomarker/Laboratory analysis, Treatment Closed Not specified Other CRUK-neo-tAnGo
EU-20316, NCT00070278

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.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

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

Expected Enrollment

800

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

Outcomes

Primary Outcome(s)

Complete pathological response after 4 courses

Secondary Outcome(s)

Survival
Disease-free survival
Effect of prognostic factors

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

Trial Contact Information

Trial Lead Organizations

Addenbrooke's Hospital

Helena Earl, MBBS, PhD, FRCP, Study coordinator
Ph: 44-1223-336-800

Registry Information

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

Registered in ClinicalTrials.gov		NCT00070278

Date Submitted to PDQ		2003-08-26

Information Last Verified		2009-01-23

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.