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

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

February 14, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complete pathological response after 4 courses [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Complete pathological response after 4 courses

Change History

Complete list of historical versions of study NCT00070278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Effect of prognostic factors [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Survival
Disease-free survival
Effect of prognostic factors

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: cyclophosphamide
Drug: epirubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Genetic: comparative genomic hybridization
Genetic: microarray analysis
Genetic: mutation analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

800

Completion Date

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00070278

Responsible Party

Study ID Numbers ^ICMJE

CDR0000331863, CRUK-neo-tAnGo, EU-20316

Study Sponsor ^ICMJE

Cambridge University Hospitals NHS Foundation Trust

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Helena Earl, MBBS, PhD, FRCP

Cambridge University Hospitals NHS Foundation Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP