Last updated on February 2018

Overcoming Endocrine Resistance in 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: Metastatic Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  1. Provision of written informed consent
  2. Histological/cytological confirmation of breast cancer
  3. Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
  4. Postmenopausal women
  5. Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
  6. Patients demonstrating prior response to AI therapy
  7. Patients with measurable disease as per RECIST criteria /Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria.
  8. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
  9. Life expectancy of at least 8 months
  10. WHO performance status 0, 1 or 2
  11. Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
  12. Are able to swallow and retain oral medication;
  13. Are able to complete all screening assessments as outlined in the protocol;
  14. Patients must have normal organ and marrow function
  15. Left ventricular ejection fraction (LVEF) within the institutional normal range

Exclusion Criteria:

  1. Previous therapy with Fulvestrant and/or Lapatinib;
  2. Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
  3. Concurrent non study anti-cancer therapy (
  4. Have unresolved or unstable, serious toxicity from prior administration
  5. Have malabsorption syndrome,
  6. Have a concurrent disease or condition that would make the patient inappropriate for study participation,
  7. Have an active or uncontrolled infection;
  8. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  9. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
  10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
  11. Receive concurrent treatment with prohibited medications
  12. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
  13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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