This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection. Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg. Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows: Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale
Via V.E. Dabormida, 64, Catania, Italy
Fondazione per la Ricerca e la Cura dei Tumori "Tommaso Campanella" Unità Operativa Complessa CRR per il Counselling Genetico e le Terapie Innovative in Oncologia Medica
Viale Europa-Loc. Germaneto, Catanzaro, Italy
Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit
Corso Spezia, 60 Torino, Italy
IRCCS Azienda Ospedaliero Universitaria San Martino di Genova - IST Genova Dipartimento Chirurgia Ospedaliera - Semeiotica Chirurgica e Chirurgia Senologica
L.go Rosanna Benzi,10 Genova, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"
Piazza Giulio Cesare 11 Bari, Italy
Azienda Ospedaliero-Universitaria Di Pisa
Pisa, Italy
Universita' Campus Bio-medico di Roma
Roma, Italy
Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina
San Giovanni Rotondo, Italy
Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica
Strada Provinciale 142 Km 3.95- Candiolo, Italy
Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica
Via Gramsci, 14 Parma, Italy
...and 3 more locations
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
End of lymphorrhea will be declared when the lymph volume measured by the patient is \< 50 ml/day in 2 consecutive days.
Time frame: 12 weeks post surgery
number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg
Safety and tolerability of LF-PB
Time frame: 12 weeks after surgery
effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain
daily volume of lymph collected from the drain
Time frame: 12 weeks after surgery
number of complications related to lymphorrhea
effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea
Time frame: 12 weeks after surgery
PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg
PK parameters
Time frame: 12 weeks after surgery
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