|
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy Clinical research trials and Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy. Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy clinical trial. Subjects typically recieve the finest healthcare available for their Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy  Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
For Condition: stage 3B breast cancer,stage 2 breast cancer,inflammatory breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , EORTC Radiotherapy Cooperative Group,Central and Eastern European Oncology Group,Grupo Oncologico Cooperativo Chileno de Investigation,International Collaborative Cancer Group
Synopsis: RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
Details: OBJECTIVES: - Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo mastectomy followed by radiotherapy. - Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options: - Regimen A: Patients receive radiotherapy alone. - Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone. - Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone. Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery. Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced breast cancer - T3 inoperable, N0-N2 - Any T, N2 - T4, N0-N2 - Inflammatory breast carcinoma - Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks - Residual tumor size less than 5 cm - No fixed axillary lymph nodes - No multifocal or bilateral breast cancer - No clinical suspicion of extensive ductal carcinoma in situ - No unresolved skin edema - No distant metastases (including ipsilateral supraclavicular node) - Positive bone scan allowed provided there are no bone metastases on x-ray - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Any age Sex: - Female Menopausal status: - Not specified Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times normal - SGOT and SGPT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal Renal: - Creatinine less than 1.5 times normal Other: - No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix - No serious underlying medical illness that would preclude study - No psychiatric or addictive disorder that would preclude study - No contraindication to study treatment - Not pregnant - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - No concurrent hormonal replacement therapy - No concurrent oral contraceptives Radiotherapy: - See Disease Characteristics - No prior radiotherapy for breast cancer Surgery: - No prior surgery for breast cancer other than biopsy for diagnosis confirmation Other: - No other prior systemic therapy for breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarzenaWelnicka-Jaskiewicz, , Medical University of Gdansk
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Arnhems Radiotherapeutisch Instituut
ARNHEM, , 6815 AD
Netherlands
Akademisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Medical University of Gdansk
Gdansk, , 80-211
Poland
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , 3049
Portugal
Karol Marcinkowski University
Poznan, , 60-355
Poland
Dr. Bernard Verbeeten Instituut
Tilburg, , 5042 SB
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Centre Hospitalier Etterbeek Ixelles
Brussels, , B-1050
Belgium
Instituto de Radiomedicina
Santiago, , 10
Chile
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Rambam Medical Center
Haifa, , 31096
Israel
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
Additional Information:
Study ID Numbers: CDR0000069121; LAMANOMA,EORTC-10974,GOCCHI-EORTC-10974,EORTC-BIG-0002,ICCG-EORTC-10974,EORTC-22002,CEEOG-EORTC-10974
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028704
Other Stage 3b Breast Cancer Studies:
1. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
2. Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
3. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
4. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
5. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
Related Studies:
Other stage 3B breast cancer Clinical Trials
Other Clinical Trials
Other Coimbra Clinical Trials
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
|
|
|
|
|
|
|
|
