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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00004237

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: vinorelbine tartrate Procedure: conventional surgery Radiation: radiation therapy	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 1998

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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