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CompletedNCT00004237Updated Nov 6, 2013

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

A Phase 2 interventional study of cyclophosphamide and doxorubicin hydrochloride in Breast Cancer, sponsored by Royal Marsden NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Royal Marsden NHS Foundation Trust · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage I breast cancer
  • stage II breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)

Interventions

  • Drugcyclophosphamide
  • Drugdoxorubicin hydrochloride
  • Drugepirubicin hydrochloride
  • Drugmitoxantrone hydrochloride
  • Drugvinorelbine tartrate
  • Procedureconventional surgery
  • Radiationradiation therapy
06

Study locations

1 site
  • Royal Marsden NHS Foundation Trust - Surrey
    Sutton, England SM2 5PT, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004237
Lead sponsor
Royal Marsden NHS Foundation Trust
First posted
Jan 27, 2003
Start date
Oct 1998
Completion
Sep 2005
Last update
Nov 6, 2013

Study contacts

Ian E. Smith, MD
study chair · Royal Marsden NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2005. You cannot join it, but the record below documents what was studied.

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