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Clinical trials in breast cancer in Italy: the Gruppo Italiano Mammella (GIM)

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. GIM group. Intergroup: GONO-GOCSI-GOIRC-GOL Participating centers: 100 italian centers

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Clinical trials in breast cancer in Italy: the Gruppo Italiano Mammella (GIM)

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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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