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Comprehensive Review of Breast Cancer Clinical Trials in Italy

Explore significant studies by the Gruppo Italiano Mammella in Italy focusing on adjuvant chemotherapy, taxanes, and endocrine therapy for early breast cancer patients. Investigate survival outcomes, treatment regimens, and patient cohorts. Stay updated on ongoing and closed protocols.

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Comprehensive Review of Breast Cancer Clinical Trials in Italy

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  1. Clinical trials in breast cancer in Italy: the Gruppo Italiano Mammella (GIM) Lucia Del Mastro Istituto Nazionale per la Ricerca sul Cancro Genoa – Italy Roma, 16 Novembre 2006

  2. GIM group • Intergroup: GONO-GOCSI-GOIRC-GOL • Participating centers: 100 italian centers • Main focus: phase III study in early breast cancer • Chemotherapy • Endocrine therapy • Supportive care

  3. Adjuvant chemotherapy trials • Role oftaxanes innode negative patients • GIM-1 study • Role ofdose-denseand role ofthree-drug regimen as compared to two-drugregimen in taxane-containing chemotherapy in node positive patients • GIM-2 study

  4. GIM 1 study A phase III randomized study of sequential Epidoxorubicin plus Cyclophospamide followed by Docetaxel (ECD) versus the combination of 5-Fluorouracil, Epidoxorubicin and Cyclophospamide (FEC) as adjuvant treatment of node-negative early breastcancer patients

  5. GIM 1: phase III randomized study EC 90/600 q21 x 4 DOCETAXEL 100 q21 x 4 FEC 600/75/600 q21 x 6

  6. STUDY OBJECTIVES • Primary objective: • to compare Disease Free Survival (DFS) between treatment groups • Secondary objective: • to compare Overall Survival (OS) • to compare Safety

  7. Study details • Start date: 13/11/2003 • Protocol status: ongoing • Participating centers:84 • Total randomized patients: 842

  8. Protocol GIM 2 A phase III randomized study of EC followed by Paclitaxel versus FEC followed by Paclitaxel, all given either every 3 weeks or 2 weeks supported by Pegfilgrastim, for node positive breast cancer patients

  9. GIM-2: study design and objectives ARM A EC x 4  T x 4q. 3 w ARM C EC x 4  T x 4 q. 2 w + Pegfilgrastim ARM B FEC x 4  T x 4 q. 3 w ARM D FEC x 4  T x 4 q. 2 w + Pegfilgrastim • Factorial study aimed at assessing two separate hypothesis: • Factor 1: A+C vs B+D = the efficacy and safety of 5-FU in addition to ECT • Factor 2: A+B vs C+D =the efficacy and safety of a 50% increase in dose-density

  10. Study objectives • Primary objective: • to compare Disease Free Survival (DFS) from adding of 5-Fluorouracil to EC followed by Paclitaxel • to compare Disease Free Survival (DFS) of schedule every 2 weeks versus 3 weeks • Secondary objective: • to compare Safety

  11. Study details • Start date: 20/03/2003 • Protocol status: closed03/07/2006 • Participating centers: 91 • Total randomized patients: 2091

  12. PROTOCOL GIM4 LETROZOLE ADJUVANT THERAPY DURATION STUDY (LEAD): STANDARD VERSUS LONG TREATMENT with AROMATASE INHIBITORS A PHASE III STUDY IN POSTMENOPAUSAL WOMEN WITH EARLY BREAST CANCER

  13. Study design Phase III randomized study • Postmenopausal • TAM 2-3 yrs LETROZOLE 3-2 YRS LETROZOLE 5 YRS

  14. Study objectives • Primary objective: • tocompare Disease Free Survival (DFS) between treatment groups • Secondary objectives: • tocompare Overall Survival (OS) • to compare Safety

  15. Study details • Start date: 27/07/05 • Protocol status: ongoing • Participating centers: 64 • Total randomized patients: 500

  16. PROTOCOL GIM-5CYPLECSTUDY: CYP19 LETROZOLECORRELATION STUDY Letrozole Extended-Adjuvant Therapy After Tamoxifen Study of Gene CYP19 Correlation with Letrozole Efficacy in Postmenopausal Early Breast Cancer Patients

  17. CYPLEC – GIM 5Multicenter, not comparative, prospective, phase IIIb study of GIM group Postmenopausal pts ER and/or PgR + Tamoxifen 4,5-6 yrs. Letrozole 5 years Registration Total Patients:2400 during a 3-year period Primary objective: correlation between a Single Nucleotide Polymorphism (SNP) of CYP19 and Disease Free Survival (DFS) Hypothesis: 86% of power to detect a relative reduction of relapse of 46%: 4-yrs DFS for TC genotype = 91% 4-yrs DFS for CC or TT genotype = 95%

  18. Study objectives • PRIMARY OBJECTIVE Correlation DFS - SNP of CYP19 gene • SECONDARY OBJECTIVES Correlation SNP of CYP19 gene and: 1) letrozole plasma concentration 2) aromatase inhibition by plasma estrone-S 3) OS 4) Safety

  19. Study details • Start date: 27/07/05 • Protocol status: ongoing • Participating centers: 64 • Total enrolled patients: 162

  20. Protocol Promise Prevention of chemotherapy – induced menopause by temporary ovarian suppression with Triptorelin vs control in young breast cancer patients. A randomized phase III multicenter study

  21. Study design Randomized phase III study Age <45 yrs Stage I-II-III Candidate for chemotherapy Only CT CT + Triptorelin

  22. Study Objectives • Primary objective: • to evaluate efficacy of Triptorelin to prevent chemotherapy-induced amennorreha • Secondary objective: • to compare safety of chemotherapy associated to Triptorelin vs only chemotherapy

  23. Study details • Start date: 29/05/2003 • Protocol status: ongoing • Participating Centers: 24 • Total randomized patients: 188

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