1. nab-Paclitaxel Sviluppi Futuri nel Carcinoma Mammario

2. nab-Paclitaxel Studi Europei Ongoing
Trial Description
Country
Phase
A multicenter phase II trial of nab-paclitaxel and Capecitabine as first line treatment in HER2 negative metastatic breast cancer
ITALY II
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
SPAIN
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)
GERMANY
III
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

3. nab-Paclitaxel Studi “Ready to start”
Trial Description
Country
Phase
Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer
ETNA
ITALY
III
A randomized phase II study evaluating three different schedules of nab-paclitaxel as first line chemoterapy in metastatic breast cancer
SNAP II
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

4. Studio GOIM
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

5. Studio GOIM Disegno dello Studio
Nab-paclitaxel 150 mg/m2 IV in 30 min GG 1-8 q3w
Capecitabina
825 mg/m2 Orale bid
GG 1-14 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)
bid, twice daily; IV, intravenous; MBC, metastatic breast cancer; q3w, every 3 weeks.

6. 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
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

7. Studio GEICAM Disegno dello studio52 5
MA 1219
:46:51 PM
ESA 1256
:05:26 PM 69 5 7

8. Studio GeparSepto
A randomized phase III trial comparing nanoparticle-based paclitaxel with solvent-based paclitaxel as part of neoadjuvant chemotherapy for patients with early breast cancer
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
Core biopsy
Core biopsy
Core biopsy
Surgery
if HER2-positive:
Trastuzumab
if HR-positive: Tamoxifen, Aromatase-Inhibitor
According to AGO recommendation
N = 1.200 R
12 weeks
12 weeks
Stratification:
- Subgroup HER2/HR
- Ki67
- SPARC
If HER2-positive:
Trastuzumab 8 mg/kg (loading dose) followed by 6 mg/kg
Pertuzumab 840 mg (loading dose) followed by 420 mg
Paclitaxel
80 mg/m2
weekly
nab-Paclitaxel
150 mg/m2 weekly
Epirubicin 90 mg/m2
Cyclophosphamide 600 mg/m2

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 StudionP nP nP C C C
Pegfilgrastim q2w, Epoetin (Darbepoetin-α, Epoetin-β)
N=2.886
Epirubicin 150mg/m2 q2w nab-Paclitaxel q2w Cyclophosphamide 2g /m2 q2w
(Definition of dose by run-in Phase) R E E E E +1
week break D D D D C C C C
Pegfilgrastim q2w, Epoetin (Darbepoetin-α, Epoetin-β)
EC 90/600 mg/m², q2w x Docetaxel 75 mg/m², q2w x 4
tailored tailored

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

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

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

16. Studio SNAP
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

17. SNAP Disegno dello Studio
nab-pac- 75 mg/m2 days 1,8,15,22 C
Randomization allocation 1:1:1 (A:B:C)
Note that the schedules of 150 mg/m2 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

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
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
nab-paclitaxel 125 mg/m2
day 1, 8, 15 q 28
nab-paclitaxel 100mg/m2 R
till disease progression or toxicity
Stratification factors:
age vs ≥ 75 yrs
diabetes yes, no  
G3-4 CIRS yes, no
IADL deficient yes, no