drugset / Trial / NCT00688194

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

NCT00688194

Phase 3 Unknown 396 enrolled Gruppo Italiano Mammella (GIM)
RandomizedDouble-blindTreatment

Summary

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.

Timeline

Start
2008-05
Primary completion
2013-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified
Comparator Exemestane Small molecule
Comparator Lapatinib Small molecule Oral
Comparator Letrozole Other / unclassified
Comparator Fulvestrant Small molecule Intramuscular

Indications