Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004237
First received: January 28, 2000
Last updated: February 26, 2011
Last verified: May 2005
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Epirubicin hydrochloride
Epirubicin
Mitoxantrone
Mitoxantrone hydrochloride
Vinorelbine
Vinorelbine tartrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | October 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004237
Locations
| United Kingdom | |
| Royal Marsden NHS Foundation Trust - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
| Study Chair: | Ian E. Smith, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004237 History of Changes |
| Other Study ID Numbers: | CDR0000067481, RMNHS-TOPIC2, EU-99037 |
| Study First Received: | January 28, 2000 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Vinorelbine Doxorubicin Epirubicin Mitoxantrone Vinblastine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 22, 2013