ECTO, FM-B – Contact Details
Country
Europe
Chair
L. Gianni, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via Venezian 1, 20133 MILAN, ITALY. Tel: +39 2 2390 2789 Fax: +39 2 2390 2678
Data Center
Michelangelo Operations Office, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via Venezian 1, 20133 MILAN, ITALY. Tel: +39 2 2390 2206/2352 Fax: +39 2 2390 2678
ECTO – Study Details
Title
European cooperative study of chemotherapy and surgery comparing adjuvant doxorubicin followed by CMF versus adjuvant doxorubicin/paclitaxel followed by CMF versus primary doxorubicin/paclitaxel followed by CMF in women with operable breast cancer and T > 2cm.
Coordinator(s)
L. Gianni, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via Venezian 1, 20133 MILAN, ITALY. Tel: +39 2 2390 2206/2352 Fax: +39 2 2390 2678
Summary
- Opened in November 1996
- Target accrual: 1250 patients
Objectives
- To evaluate whether 8 cycles of primary chemotherapy before adequate surgery of breast tumor and loco-regional radiotherapy + tamoxifen for 5 years improves the disease-free (DFS) and overall survival (OS) in women with operable breast carcinoma and T > 2cm in diameter at diagnosis.
- To assess whether, in the postoperative arms, the addition of paclitaxel to doxorubicin before CMF improves DFS and OS in these patients.
Scheme
Update
- Enrolment completed as of May 2002; 1355 patients.
Related Publications
Gianni L, Baselga J, Eiermann W et al., for the ECTO Study Group. European Cooperative Trial in Operable Breast Cancer (ECTO): improved freedom from progression (FFP) from adding paclitaxel (T) to doxorubicin (A) followed by Cyclophosphamide Methotrexate and Fluorouracil (CMF); Abstract ASCO 2005.
Gianni L, Baselga J, Eiermann W et al. Feasibility and tolerability of sequential doxorubicin/paclitaxel followed by cyclophosphamide, methotrexate, and fluorouracil and its effects on tumor response as preoperative therapy. Clin Cancer Res 2005; 11(24).
Topics
None available
Keywords
None available
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Title
European Cooperative Study of Primary Systemic Therapy in Women with Operable Breast Cancer and T > 2cm.
Coordinator(s)
L. Gianni, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via Venezian 1, 20133 MILAN, ITALY. Tel: +39 2 2390 2206/2352 Fax: +39 2 2390 2678
Summary
- Opened in June 2005.
- Overall study design: This is a cooperative, multicenter, open-label trial, consisting of two parallel phase II randomized studies: Study 1, ER-negative tumors and Study 2, ER-positive tumors.
- Target accrual: 315 patients for Study 1 and 171 for Study 2.
Objectives
- To assess the rate of pathological complete remission (pCR) in ER-negative (Study 1) and ER-positive (Study 2) operable breast cancer.
- To assess the rate of objective clinical remission (OR) after the first 4 cycles of each chemotherapy regimen and at the end of the entire primary program.
- To assess tolerability and safety of each proposed regimen.
Scheme
Update
- 128 Patients enrolled as of September 2006
Related Publications
None available
Topics
None available
Keywords
None available
