Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

Sponsor
Gruppo Italiano Mammella (GIM)
Study ID
NCT00688194
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • anastrozole — DRUG
    Patients receive aromatase inhibitor therapy according to standard treatment regulations.
  • exemestane — DRUG
    Patients receive aromatase inhibitor therapy according to standard treatment regulations.
  • fulvestrant — DRUG
    Given intramuscularly
  • lapatinib ditosylate — DRUG
    Given orally
  • letrozole — DRUG
    Patients receive aromatase inhibitor therapy according to standard treatment regulations.
  • placebo — OTHER
    Given orally

Study Details

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant and exemestane, anastrozole, or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells and by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib and/or aromatase inhibitor therapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying fulvestrant with or without lapatinib and/or aromatase inhibitor therapy to compare how well they work in treating postmenopausal women with metastatic breast cancer that progressed after previous aromatase inhibitor therapy.

Key Dates

Start date
May 31, 2008
Status verified
May 2008
Primary completion
May 31, 2013

Study Design

Enrollment
396 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I
    Patients receive fulvestrant intramuscularly (IM) on days 0, 14, and 28 of course 1 and on day 1 of all subsequent courses. Patients also receive oral placebo once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II
    Patients receive fulvestrant and placebo as in arm I. Patients also receive aromatase inhibitor (AI) therapy (e.g., exemestane, anastrozole, or letrozole) according to standard treatment regulations.
  • Active Comparator: Arm III
    Patients receive fulvestrant as in arm I and oral lapatinib tosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm IV
    Patients receive fulvestrant as in arm I and lapatinib as in arm III. Patients also receive AI therapy according to standard treatment regulations.

Primary Outcome Measure

Progression-free survival

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