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Completed

NCT Number: NCT01754285

Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea

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.

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Key information

Conditions

Lymphorrhea

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale, Via V.E. Dabormida, 64, Catania, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 18 to 80 years inclusive
  • Body mass index (BMI) ≥18 kg/m2
  • Signed informed consent form
  • Diagnosis of BC
  • Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
  • Negative serum pregnancy test for women of childbearing potential Note: Female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
  • AST and alanine aminotransferase ALT <1.5 x the upper limit of normal
  • Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.

Exclusion criteria

  • Presence of any of the following conditions:
  • Previous axillary surgery on the same armpit undergoing surgery in this study
  • Previous chemotherapy or radiotherapy within five years from study drug administration
  • Previous neoadjuvant therapy
  • Recurrent BC on the same breast undergoing surgery in this study
  • Diabetes
  • Cholelithiasis
  • Hypothyroidism. If patient is being administered Euritox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study.
  • Hepatitis
  • Pregnant or lactating
  • Human immunodeficiency virus or hepatitis B or C by screening serology
  • History of radiotherapy on the same breast or armpit undergoing surgery in this study.
  • History of anaphylaxis to study drug
  • Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
  • QTc interval extension at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart)
  • Presence of any disease or use of concomitant medication known to increase the QT interval (see Appendix 2 for a list of such compounds)
  • Clinically significant or relevant abnormal medical history, vital sign, physical examination, ECG, or laboratory evaluation finding
  • Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study

Treatment and study plan

LF-PB and Placebo

Drug

Other names: extended-release of octreotide and placebo

Placebo

Drug

LF-PB

Drug

Other names: LF-PB 10 mg and LF-PB 20 mg

Primary outcomes

  1. effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;

    Time frame: 12 weeks post surgery

    End of lymphorrhea will be declared when the lymph volume measured by the patient is < 50 ml/day in 2 consecutive days.

  2. number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg

    Time frame: 12 weeks after surgery

    Safety and tolerability of LF-PB

Secondary outcomes

  1. effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain

    Time frame: 12 weeks after surgery

    daily volume of lymph collected from the drain

  2. number of complications related to lymphorrhea

    Time frame: 12 weeks after surgery

    effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea

  3. PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg

    Time frame: 12 weeks after surgery

    PK parameters

Other outcomes

  1. correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg

    Time frame: 12 weeks after surgery

    correlation between exposure of the drug and efficacy

Sponsors and collaborators

Lead sponsor

Chemi S.p.A.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.