nab-Paclitaxel

nab-Paclitaxel
Sviluppi Futuri nel
Carcinoma
Mammario
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
II
A Randomized Phase III Trial Comparing Nanoparticle-based Paclitaxel With Solventbased 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 dosedense, tailored therapy with dtEC-dtD for patients with high-risk primary breast cancer
GERMANY
III
nab-Paclitaxel
Studi “Ready to start”
Trial Description
Country
Phase
Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative highrisk 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
ITALY
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
ITALY
II
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
Studio GOIM
Disegno dello Studio
Nab-paclitaxel
150 mg/m2 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)
bid, twice daily; IV, intravenous; MBC, metastatic breast cancer; q3w, every 3 weeks.
Capecitabina
825 mg/m2 Orale bid
GG 1-14 q3w
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
Studio GEICAM
Disegno dello studio
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 nabpaclitaxel 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
GeparSepto
Disegno dello Studio
Core biopsy
Core biopsy
Core biopsy
N = 1.200
R
12 weeks
12 weeks
Surgery
if HER2-positive:
Trastuzumab
if HR-positive:
Tamoxifen,
Aromatase-Inhibitor
According to AGO
recommendation
Stratification:
- Subgroup HER2/HR
- Ki67
- SPARC
If HER2-positive:
Paclitaxel
80 mg/m2
weekly
nab-Paclitaxel
150 mg/m2
weekly
Epirubicin 90 mg/m2
Cyclophosphamide 600 mg/m2
Trastuzumab 8 mg/kg (loading
dose) followed by 6 mg/kg
Pertuzumab 840 mg (loading dose)
followed by 420 mg
Studio GeparSepto
Disegno dello studio
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
GAIN II
Disegno dello Studio
E
E
nP
nP
nP
C
C
C
Pegfilgrastim q2w, Epoetin (Darbepoetin-α, Epoetin-β)
N=2.886
R
E
®
Epirubicin 150mg/m2 q2w
nab-Paclitaxel q2w
Cyclophosphamide 2g /m2 q2w
(Definition of dose by run-in Phase)
E
E
E
E
C
C
C
C
+1
week break
D
D
D
Pegfilgrastim q2w, Epoetin (Darbepoetin-α, Epoetin-β)
EC 90/600 mg/m², q2w x 4
tailored
Docetaxel 75 mg/m², q2w x 4
tailored
D
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
Studio ETNA
Adapted from STRATEGIES for SELECTING THERAPY in HERNEGATIVE BREAST
CANCER, ESMO Vienna 2012, prIME Oncology activity Satellite Symposium
ETNA
Disegno dello Studio
Adapted from STRATEGIES for SELECTING THERAPY in HERNEGATIVE BREAST
CANCER, ESMO Vienna 2012, prIME Oncology activity Satellite Symposium
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
SNAP
Disegno dello Studio
N=240
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
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)
EFFECT
Disegno dello Studio
Age ≥ 65
Locally recurrent or metastatic HER2-neg breast cancer or HER2positive but considered not eligible for anti-HER2 therapy
No prior CT for advanced breast cancer
Measurable or evaluable disease
N=156
R
nab-paclitaxel 125 mg/m2
day 1, 8, 15 q 28
nab-paclitaxel 100mg/m2
day 1, 8, 15 q 28
till disease progression or toxicity
Stratification factors:
age 65-74 vs ≥ 75 yrs
diabetes yes, no
G3-4 CIRS yes, no
IADL deficient yes, no