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Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
cyclophosphamide
epirubicin hydrochloride
fluorouracil
paclitaxel
Sponsored by
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed stage IIA, IIB, or III breast cancer treated with radical surgery (e.g., mastectomy, quadrantectomy, tumorectomy) and axillary lymph node dissection Positive axillary lymph nodes No more than 9 metastatic lymph nodes No distant metastases or local or locoregional disease No more than 5 weeks between surgery and beginning of study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Not specified Performance status: ECOG 0 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Transaminases, alkaline phosphatase, and gamma glutamyltransferase no greater than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No heart disease that precludes use of anthracyclines (i.e., myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmias, or valve disease) Other: No concurrent pathology that precludes use of antineoplastic drugs No mental retardation or psychiatric disease that precludes study No other current or prior malignancy within the past 10 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior antineoplastic hormonal therapy Radiotherapy: No postoperative radiotherapy except to residual breast Surgery: See Disease Characteristics

Sites / Locations

  • Ospedale San Lazzaro
  • Ospedale Civile di Asti
  • Ospedale Oncologico A. Businco
  • Santo Spirito Hospital
  • Ospedale Santa Croce
  • Ospedale Galliera Oncologia
  • Istituto Nazionale per la Ricerca sul Cancro
  • Ospendale S. Andrea EST
  • Ospedale Civile di Livorno
  • Carlo Poma Hospital
  • Azienda USSL NO 8
  • Instituto Scientifico H.S. Raffaele
  • Ospedale Santa Croce
  • I.R.C.C.S. Policlinico San Matteo
  • Ospedale St. Santa Chiara
  • USL NO 1
  • Azienda U.S.L. 1 - Sassari
  • Ospedale S. Paolo
  • Osp. Civile USL 18
  • Ospedale Sant Anna
  • Ospedale Evangelico Valdese
  • OIRM - Sant Anna
  • Ospedale Mauriziano Umberto I
  • Ospedale Maggiore dell' Universita
  • Ospedale Molinette

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
December 17, 2013
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00005581
Brief Title
Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Official Title
Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

4. Oversight

5. 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. It is not yet known which regimen of chemotherapy is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating women who have stage II or stage III breast cancer.
Detailed Description
OBJECTIVES: I. Compare overall survival and disease free survival after adjuvant chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide, epirubicin, and fluorouracil in women with stage IIA, IIB, or III breast cancer. II. Compare quality of life in these women with these treatment regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms within 35 days of surgery. Arm I: Patients receive epirubicin IV followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses. Arm II: Patients receive cyclophosphamide IV, epirubicin IV, and fluorouracil IV on day 1. Treatment repeats every 21 days for 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are postmenopausal, or premenopausal and hormone receptor positive, receive tamoxifen orally once a day for 5 years starting on day 1. Patients receive radiotherapy to residual breast after 4 courses of chemotherapy. Quality of life is assessed. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study over 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIA, IIB, or III breast cancer treated with radical surgery (e.g., mastectomy, quadrantectomy, tumorectomy) and axillary lymph node dissection Positive axillary lymph nodes No more than 9 metastatic lymph nodes No distant metastases or local or locoregional disease No more than 5 weeks between surgery and beginning of study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Not specified Performance status: ECOG 0 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Transaminases, alkaline phosphatase, and gamma glutamyltransferase no greater than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No heart disease that precludes use of anthracyclines (i.e., myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmias, or valve disease) Other: No concurrent pathology that precludes use of antineoplastic drugs No mental retardation or psychiatric disease that precludes study No other current or prior malignancy within the past 10 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior antineoplastic hormonal therapy Radiotherapy: No postoperative radiotherapy except to residual breast Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Rosso, MD
Organizational Affiliation
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale San Lazzaro
City
Alba
ZIP/Postal Code
12051
Country
Italy
Facility Name
Ospedale Civile di Asti
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Ospedale Oncologico A. Businco
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Santo Spirito Hospital
City
Casale Monferato
ZIP/Postal Code
1-15033
Country
Italy
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale Galliera Oncologia
City
Genoa
ZIP/Postal Code
16128
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospendale S. Andrea EST
City
La Spezia
ZIP/Postal Code
19100
Country
Italy
Facility Name
Ospedale Civile di Livorno
City
Livorno
ZIP/Postal Code
57121
Country
Italy
Facility Name
Carlo Poma Hospital
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Azienda USSL NO 8
City
Merate
ZIP/Postal Code
22055
Country
Italy
Facility Name
Instituto Scientifico H.S. Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale Santa Croce
City
Moncalieri
ZIP/Postal Code
10024
Country
Italy
Facility Name
I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale St. Santa Chiara
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
USL NO 1
City
San Remo
ZIP/Postal Code
18038
Country
Italy
Facility Name
Azienda U.S.L. 1 - Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale S. Paolo
City
Savona
ZIP/Postal Code
17100
Country
Italy
Facility Name
Osp. Civile USL 18
City
Sestri Lev.
ZIP/Postal Code
16039
Country
Italy
Facility Name
Ospedale Sant Anna
City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
Ospedale Evangelico Valdese
City
Torino
ZIP/Postal Code
10125
Country
Italy
Facility Name
OIRM - Sant Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Ospedale Maggiore dell' Universita
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Facility Name
Ospedale Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

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