Overcoming Endocrine Resistance in Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Consorzio Oncotech
• Treatments: Aromatase Inhibitors; Estradiol; Fulvestrant; Lapatinib

Criteria

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.