Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004237
• Other study ID #: CDR0000067481
• Secondary ID: RMNHS-TOPIC2EU-9
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2000
• Last updated: November 5, 2013
• Start date: October 1998
• Est. completion date: September 2005

Study information

• Verified date: May 2005
• 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer.

Description:

OBJECTIVES:

• Determine the efficacy of vinorelbine/epirubicin and vinorelbine/mitoxantrone in terms of clinical objective tumor response, clinical complete remission, and pathological complete remission in women with early stage breast cancer.

• Compare the efficacy of these 2 new regimens with an established regimen of cyclophosphamide/doxorubicin in a randomly selected control group of patients.

• Compare the toxicity and side effects of these 2 new regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and age (under 50 vs 50 and over). Patients are randomized to one of three treatment arms.

• Arm I: Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1.

• Arm II: Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1.

• Arm III: Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease progression. All patients except those who are under 50 and whose tumors are estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy.

All patients are offered surgery following completion of chemotherapy. Radiotherapy begins within 4 weeks of completion of chemotherapy or surgery, whichever is the immediately preceding treatment.

Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 62-125 patients will be accrued for this study within 12-18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary breast cancer that is potentially operable

• Synchronous bilateral tumors eligible

• At least 3 cm in maximum diameter

• Tumors at least 2 cm eligible provided primary chemotherapy is deemed appropriate and radical surgery would otherwise be required

• No evidence of metastatic disease

• No prior breast cancer

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled angina pectoris

• No heart failure

• No clinically significant uncontrolled cardiac arrhythmias

• LVEF at least 50%

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No medical or psychiatric condition that impairs ability to cope physically or psychologically with the chemotherapy regimen

• No other serious uncontrolled medical condition

• No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• epirubicin hydrochloride

• mitoxantrone hydrochloride

• vinorelbine tartrate

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,