Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
Summary
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.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LF-PB | Unknown | 10 mg | Intramuscular |
| Subject | LF-PB | Unknown | 20 mg | Intramuscular |
| Subject | LF-PB | Unknown | 30 mg | Intramuscular |
Indications
No indication recorded.