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Nab-Paclitaxel Sviluppi Futuri nel Carcinoma Mammario.

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Presentation on theme: "Nab-Paclitaxel Sviluppi Futuri nel Carcinoma Mammario."— Presentation transcript:

1 nab-Paclitaxel Sviluppi Futuri nel Carcinoma Mammario

2 Trial DescriptionCountryPhase A multicenter phase II trial of nab-paclitaxel and Capecitabine as first line treatment in HER2 negative metastatic breast cancer ITALYII A phase II, open-label, non-randomized study of nab-paclitaxel for patients with stage II and III luminal breast cancer as neo-adjuvant treatment SPAINII A Randomized Phase III Trial Comparing Nanoparticle-based Paclitaxel With Solvent- based Paclitaxel as Part of Neoadjuvant Chemotherapy for Patients With Early Breast Cancer (Gepar Septo) GERMANYIII Adjuvant phase III trial to compare intense dose-dense treatment with EnPC to dose- dense, tailored therapy with dtEC-dtD for patients with high-risk primary breast cancer GERMANYIII nab-Paclitaxel Studi Europei Ongoing

3 Trial DescriptionCountryPhase Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high- risk breast cancer ETNA ITALYIII A randomized phase II study evaluating three different schedules of nab-paclitaxel as first line chemoterapy in metastatic breast cancer SNAP ITALYII A randomized phase II study to evaluate the efficacy and impact on function of two different doses of nab-paclitaxel in elderly patients with advanced breast cancer EFFECT ITALYII nab-Paclitaxel Studi “Ready to start”

4 A multicenter phase II trial of nab-paclitaxel and Capecitabine as first line treatment in HER2 negative Metastatic Breast Cancer Primary endpoint: The efficacy of combination in terms of response rate (RR) according to RECIST criteria The progression free survival (PFS) Secondary endpoints: Overall survival (OS) Tolerability and safety of the combination regimen according to CTC criteria Studio GOIM

5 bid, twice daily; IV, intravenous; MBC, metastatic breast cancer; q3w, every 3 weeks. Nab-paclitaxel 150 mg/m 2 IV in 30 min GG 1-8 q3w N = fino a 94 Pazienti con ECOG PS 0-1, HER2-, inclusi TN, adeguata funzionalità d’organo 6 cicli (+ 2 a discrezione del clinico) N = fino a 94 Pazienti con ECOG PS 0-1, HER2-, inclusi TN, adeguata funzionalità d’organo 6 cicli (+ 2 a discrezione del clinico) Studio GOIM Disegno dello Studio + Capecitabina 825 mg/m 2 Orale bid GG 1-14 q3w

6 Study GEICAM is a multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-Paclitaxel in the neoadjuvant treatment of ER positive HER2 negative patients amenable to receive neoadjuvant chemotherapy Primary endpoint:  Determine percentage of patients with poor response in contrast to good response (residual cancer burden) Secondary endpoints:  pCRR after surgery, Clinical response (RECIST), Invasive disease-free survival, Correlation of Ki67, gp-60, caveolin-1, SPARC and PAM50 gene expression assay with efficacy, Tolerability Studio GEICAM A phase II, open-label, non-randomized study of nab-paclitaxel for patients with stage II and III luminal breast cancer as neo-adjuvant treatment

7 Studio GEICAM Disegno dello studio

8 A randomized phase III trial comparing nanoparticle-based paclitaxel with solvent-based paclitaxel as part of neoadjuvant chemotherapy for patients with early breast cancer Studio GeparSepto Primary endpoint: To compare pCR rates of neo-adjuvant treatment with nab- paclitaxel with solvent-based paclitaxel Secondary endpoints: Assess the pCR rates for stratified subgroups, Assess various pCR rates, Determine response rates of breast tumor and axillary nodes, Clinical remission rate by taxane use, Rate of breast conservative surgery, Toxicity and compliance, Determine pCR and LRFS in patients with a cCR and a negative core biopsy before surgery

9 GeparSepto Disegno dello Studio Surgery 12 weeks N = R Stratification: - Subgroup HER2/HR - Ki67 - SPARC Paclitaxel 80 mg/m 2 weekly nab-Paclitaxel 150 mg/m 2 weekly Epirubicin 90 mg/m 2 Cyclophosphamide 600 mg/m 2 If HER2-positive: Trastuzumab 8 mg/kg (loading dose) followed by 6 mg/kg Pertuzumab 840 mg (loading dose) followed by 420 mg if HER2-positive: Trastuzumab if HR-positive: Tamoxifen, Aromatase-Inhibitor According to AGO recommendation Core biopsy

10 Studio GeparSepto Disegno dello studio

11 Studio GAIN II Adjuvant phase III trial to compare intense dose-dense treatment with EnPC to dose-dense, tailored therapy with dtEC-dtD for patients with high-risk primary breast cancer Primary endpoint: Invasive disease free survival (IDFS) Secondary endpoints: DDFS and OS, Brain metastasis free survival (in the subgroups of TNBC and HER2+ breast cancer patients), Compliance and safety, Quality of life

12 GAIN II Disegno dello Studio Epirubicin 150mg/m 2 q2w nab-Paclitaxel q2w Cyclophosphamide 2g /m 2 q2w (Definition of dose by run-in Phase) E C CCC EEE ® EC 90/600 mg/m², q2w x 4 Docetaxel 75 mg/m², q2w x 4 tailored DDDD EECEnP CC R +1 week break Pegfilgrastim q2w, Epoetin (Darbepoetin-α, Epoetin-β) N=2.886

13 Adapted from STRATEGIES for SELECTING THERAPY in HERNEGATIVE BREAST CANCER, ESMO Vienna 2012, prIME Oncology activity Satellite Symposium Studio ETNA Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer

14 Adapted from STRATEGIES for SELECTING THERAPY in HERNEGATIVE BREAST CANCER, ESMO Vienna 2012, prIME Oncology activity Satellite Symposium Studio ETNA

15 Adapted from STRATEGIES for SELECTING THERAPY in HERNEGATIVE BREAST CANCER, ESMO Vienna 2012, prIME Oncology activity Satellite Symposium ETNA Disegno dello Studio

16 A randomized phase II study evaluating three different schedules of nab-paclitaxel in metastatic breast cancer Primary endpoint: Progression Free Survival (PFS) Secondary endpoints: Adverse events according to CTCAE v4 Feasibility: completing treatment according to the protocol for at least 24 weeks Disease control: stable disease for ≥24 weeks or confirmed overall partial response or complete response Overall survival: time from randomization to death from any cause Studio SNAP

17 SNAP Disegno dello Studio Randomization allocation 1:1:1 (A:B:C) Note that the schedules of 150 mg/m 2 differ in induction (days 1,8,15) and maintenance arm B (days 1,15) nab-paclitaxel administered in 28 day cycles Continue treatment until progressive disease (PD) or unacceptable toxicity nab-pac- 75 mg/m 2 days 1,8,15,22 N=240 C

18 Studio EFFECT A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer Primary endpoint: Event-free survival (EFS) where an event is either disease progression or death or decline in functional status Secondary endpoints: Objective response rate (ORR) Clinical benefit rate (CBR) Progression free survival (PFS) Overall survival (OS) Incidence of Adverse events (defined by CTCAE v4.0)

19 EFFECT Disegno dello Studio nab-paclitaxel 125 mg/m2 day 1, 8, 15 q 28 nab-paclitaxel 100mg/m2 day 1, 8, 15 q 28 R till disease progression or toxicity Stratification factors: age vs ≥ 75 yrs diabetes yes, no G3-4 CIRS yes, no IADL deficient yes, no Age ≥ 65 Locally recurrent or metastatic HER2-neg breast cancer or HER2- positive but considered not eligible for anti-HER2 therapy No prior CT for advanced breast cancer Measurable or evaluable disease N=156


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