Last updated on July 2019

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other:
    Signed written informed consent
    Histologically or cytologically confirmed HER2-positive advanced or metastatic breast
    cancer which has progressed following prior therapy, which must have included
    anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting
    Females age >=18 years old
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    Life expectancy of at least 12 weeks
    Able to swallow and retain oral medications
    Incapable of becoming pregnant, or not pregnant and using an adequate form of
    contraception, i.e. a female who is of:
    non-childbearing potential (physiologically incapable of becoming pregnant),
    including any female who has had hysterectomy, bilateral oophorectomy, bilateral
    tubular ligation or is post-menopausal (total cessation of menses for at least 1
    year);
    childbearing potential must have a negative serum pregnancy test within 7 days
    prior to treatment with Octreotide if randomised to receive Octreotide or the
    first dose of Lapatinib with Capecitabine if randomised to receive no Octreotide,
    preferably as close to the first dose as possible, and must agree to use adequate
    contraception (intrauterine device, birth control pills unless clinically
    contraindicated, or barrier device) and other acceptable contraceptive methods
    during the study and continuing for at least 4 weeks after the final dose of
    treatment with Lapatinib and Capecitabine
    Subjects must complete all screening assessments as outlined in the protocol
    Subjects must complete the Functional Assessment of Chronic Illness Therapy-Diarrhoea
    (FACIT-D) and diarrhoea diary before receiving the first dose of Octreotide if
    randomised to receive Octreotide. All subjects must complete the FACIT-D and diarrhoea
    diary before receiving the first dose of Lapatinib with Capecitabine
    Prior treatment with other chemotherapeutic agents or endocrine therapy is permitted.
    All prior treatment related toxicities, except diarrhoea and alopecia, must be
    National Cancer Institute common terminology criteria for adverse events (NCI CTCAE)
    (version 4.03)<= Grade 1 at the time of randomization.Subjects with diarrhoea with any
    grade of severity within 14 days prior to randomisation are excluded from LAP117314
    Prior treatment with radiation therapy is permitted provided that at least 2 weeks
    have elapsed since the last fraction of radiation therapy prior to treatment with
    Octreotide if randomised to receive Octreotide or the first dose of Lapatinib with
    Capecitabine if randomised to receive no Octreotide, and all radiation therapy related
    AEs are <= Grade 1 at the time of randomization
    French subjects: In France, a subject will be eligible for inclusion in this study
    only if either affiliated to or a beneficiary of a social security category

You may not be eligible for this study if the following are true:

  • Concurrent treatment with an investigational agent or concurrent participation in
    another clinical study
    Administration of an investigational drug within 30 days or 5 half-lives, whichever is
    longer, prior to treatment with Octreotide for subjects randomised to receive
    Octreotide or the first dose of Lapatinib and Capecitabine for subjects randomised to
    receive no Octreotide
    Treatment with Octreotide within the 3 months prior to randomization
    Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including
    an Epidermal growth factor receptor (EGFR) and/or HER2 inhibitor), or hormonal therapy
    for treatment of cancer
    Dementia, altered mental status, or any psychiatric condition that would prohibit the
    understanding or rendering of informed consent, unless a legally acceptable
    representative could provide informed consent (if in accordance with the policies of
    the local Ethics Committee)
    Concurrent disease or condition that would make the subject inappropriate for study
    participation or any serious medical or psychiatric disorder that would interfere with
    the subject's safety or compliance with study procedures
    Diarrhoea with any grade of severity within 14 days prior to treatment with Octreotide
    for subjects randomised to receive Octreotide or within 14 days prior to the first
    dose of Lapatinib and Capecitabine for subjects randomised to receive no Octreotide
    Malabsorption syndrome, inflammatory bowel disease (ulcerative colitis, Chrohn's
    disease), irritable bowel syndrome, disease significantly affecting gastrointestinal
    function, or resection of the stomach or small bowel
    Pregnant or lactating subjects
    French subjects: the French subject has participated in any study using an
    investigational drug during the previous 30 days or 5 half-lives, whichever is longer,
    preceding the first dose of protocol treatment
    Prior treatment with Lapatinib

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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