Clinical trial · Interventional
Chemotherapy Plus Surgery in Treating Women With Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMF regimen | Drug | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGianni L, Baselga J, Eiermann W, Porta VG, Semiglazov V, Lluch A, Zambetti M, Sabadell D, Raab G, Cussac AL, Bozhok A, Martinez-Agullo A, Greco M, Byakhov M, Lopez JJ, Mansutti M, Valagussa P, Bonadonna G. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European Cooperative Trial in Operable Breast Cancer. J Clin Oncol. 2009 May 20;27(15):2474-81. doi: 10.1200/JCO.2008.19.2567. Epub 2009 Mar 30. PMID 19332727