A Pilot Study Of Estradiol Followed By Exemestane For Post-Menopausal Hormone Receptor Positive Metastatic Breast Cancer After Prior Failed Endocrine Therapy: Reversing Endocrine Resistance
OBJECTIVES:
I. To assess feasibility and toxicity associated with estradiol followed by exemestane in
the treatment of estrogen receptor positive metastatic breast cancer patients failing prior
aromatase inhibitor therapy.
II. Exploratory analysis of bio-correlates which will evaluate the mechanism of action of
this treatment combination: changes in serum M-30, a marker of mitochondrial apoptosis;
changes in number of circulating tumor cells (CTC); changes in CTC expression of ER, IGF1-R,
and M-30.
III. Exploratory analysis of Progression Free Survival (PFS).
OUTLINE: Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on
days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral
exemestane once daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Any incidence of grade 4 toxicity
Such as deep vein thrombosis requiring hospitalization or pulmonary embolism
By day 90
Yes
Robert Livingston
Principal Investigator
University of Arizona
United States: Food and Drug Administration
10-0906-04
NCT01385280
February 2011
Name | Location |
---|---|
University of Arizona Cancer Center | Tucson, Arizona 85724 |