Trials / Completed
CompletedNCT00570921
Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure
A Phase II Study of Combined Fulvestrant (Faslodex) and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Mara Chambers · Academic / Other
- Sex
- Female
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine if estrogen receptor-targeted therapy with fulvestrant used in combination with Everolimus is an effective and safe therapy for women with hormone receptor positive metastatic breast cancer after failure of aromatase inhibitor therapy.
Detailed description
Fulvestrant, which degrades ER, is used after aromatase inhibitor (AI) failure in metastatic breast cancer but resistance develops quickly. We hypothesized that using everolimus to inhibit mammalian target of rapamycin (mTOR), a key signaling pathway in endocrine resistance, may delay fulvestrant resistance in patients and thus improve its efficacy. We conducted a phase II trial of combined fulvestrant and everolimus in postmenopausal women with disease progression or relapse after an AI. Primary endpoint was time to progression (TTP) and secondary endpoints included objective response rate, clinical benefit rate (CBR), safety, and biomarker correlates. Tumor blocks were collected and biopsy of accessible tumor was done for future biomarker analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus | Everolimus tablets, two-5 mg tablets a day |
| DRUG | Fulvestrant | intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2013-02-01
- Completion
- 2015-01-01
- First posted
- 2007-12-11
- Last updated
- 2017-02-23
- Results posted
- 2014-12-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00570921. Inclusion in this directory is not an endorsement.