Breast Cancer Clinical Trial
Official title:
European Cooperative Study of Chemotherapy and Surgery Comparing Adjuvant Doxorubicin Followed by CMF vs. Adjuvant Doxorubicin/Paclitaxel Followed by CMF vs. Primary Doxorubicin/Paclitaxel Followed by CMF in Women With Operable Breast Cancer and T>2 cm
Verified date | June 2000 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells.
It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery
in treating women who have breast cancer.
Status | Completed |
Enrollment | 450 |
Est. completion date | March 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Unilateral carcinoma of the breast that has not been previously treated with standard therapies - Tumor greater than 2 cm in its maximum diameter as assessed by mammography, except: - No locally advanced disease, i.e., no tumor with direct extension to the chest wall or skin - No metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 to 70 Sex: - Female Menopausal status: - Not specified Performance status: - Karnofsky 80-100% Hematopoietic: - Granulocyte count at least 2,000/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin within upper limits of normal (ULN) - Alkaline phosphatase no greater than 1.5 times ULN - AST no greater than 1.5 times ULN - No chronic active hepatitis Renal: - Creatinine within ULN Cardiovascular: - No prior atrial or ventricular arrhythmias - No history of congestive heart failure - No myocardial infarction within the past 6 months - No uncontrolled hypertension Neurologic: - No pre-existing motor or sensory neuropathy greater than grade 1 Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No active infection - No history of second malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - No prior endocrine therapy Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery - No prior surgical biopsy of breast nodule |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Kaiser Franz Josef Hospital | Vienna | |
Czech Republic | Radiotherapy Institute | Ostrava-Poruba | |
Estonia | University of Tartu | Tartu | |
Germany | Frauenklinik Vom Roten Kreuz | Munich | |
Hungary | Semmelweis University | Budapest | |
Hungary | Uzsoki Hospital | Budapest | |
Italy | Policlinico Monteluce | Perugia | |
Italy | Ospedale St. Santa Chiara | Pisa | |
Italy | Centro di Riferimento Oncologico - Aviano | Trento | |
Italy | Universita Degli Studi di Udine | Udine | |
Italy | Ospedale San Bortolo | Vicenza | |
Latvia | Latvian Cancer Center | Riga | |
Poland | Regional Center of Oncology | Bydgoszcz | |
Poland | Jagiellonian University | Krakow (Cracow) | |
Poland | Szpital Kliniczny NR 1 | Poznan | |
Poland | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | |
Russian Federation | Moscow Clinical Dispenser | Moscow | |
Russian Federation | N. A. Semashko Central Clinical Hospital | Moscow | |
Russian Federation | Russian Academy of Medical Sciences Cancer Research Center | Moscow | |
Russian Federation | Regional Oncology Clinic | Murmansk | |
Russian Federation | Petrov Research Institute of Oncology | Saint Petersburg | |
Slovakia | St. Elizabeth Cancer Institute Hospital | Bratislava | |
Spain | Hospital de la Santa Cruz I Sant Pau | Barcelona | |
Spain | Hospital General Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Clinico Universitario - Malaga | Malaga | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Instituto Valenciano De Oncologia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Austria, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Poland, Russian Federation, Slovakia, Spain,
Gianni L, Baselga J, Eiermann W, Porta VG, Semiglazov V, Lluch A, Zambetti M, Sabadell D, Raab G, Cussac AL, Bozhok A, Martinez-Agulló A, Greco M, Byakhov M, Lopez JJ, Mansutti M, Valagussa P, Bonadonna G. Phase III trial evaluating the addition of paclit — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |