Phase 2
Completed N=40
Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00201864 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Aug 2016
Primary outcomePrimary: Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. — 6.9 months
Summary
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. |
6.9 | — |
| SECONDARY Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease) |
0; 3; 3; 17; 20; 8 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant |
20.1; 21.2 | 0.9102 |
| SECONDARY Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels |
119; 4946; 141; 5273; 161; 5537 | — |
Eligibility Criteria
Inclusion Criteria
- Proven breast cancer
- Metastatic or locally advanced breast cancer
- Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
- Postmenopausal status
- No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Adequate organ function
- Exclusion Criteria:
- No prior Exemestane or Fulvestrant
- Uncontrolled intercurrent illness including but not limited to:
- ongoing or active infection
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
- myocardial infarction within the last 3 months
- psychiatric illness/social situations that would limit compliance with study
- Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
- Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
Data sourced from ClinicalTrials.gov (NCT00201864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.