Overcoming Endocrine Resistance in Metastatic Breast Cancer

Sponsor
Consorzio Oncotech
Study ID
NCT02394496
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
    Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
  • Lapatinib — DRUG
    1500mg (TBD) O.S. qd
  • Aromatase Inhibitors — DRUG
    as indicated in the Summary Product Characteristic
  • Placebo Lapatinib — DRUG
    1500mg (TBD) O.S. qd

Study Details

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.

Key Dates

Start date
Nov 30, 2007
Status verified
Jun 2016
Primary completion
Dec 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
396 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: ARM 1
    Fulvestrant + Placebo Lapatinib
  • Experimental: ARM 2
    Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib
  • Experimental: ARM 3
    Fulvestrant + Lapatinib
  • Experimental: ARM 4
    Fulvestrant + Lapatinib + Aromatase Inhibitors

Primary Outcome Measure

Progression Free Survival [ Time Frame: Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months ]

Central Contacts

  • Clinical Research Technology
    0039089301545

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