A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole.
- Conditions
- breast carcinoma / breast cancer10006291
- Registration Number
- NL-OMON35415
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
- Adult women (* 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer.
- Postmenopausal women.
- Disease refractory to non steroidal aromatase inhibitors (NSAI).
- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to randomization.
- ECOG Performance Status * 2.
-Patients must have:
1. At least one lesion that can be accurately measured in at least one dimension * 20 mm with conventional imaging techniques or * 10 mm with spiral CT or MRI or
2. bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease.
- HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
- Patients who received more than one chemotherapy regimen for ABC.
- Previous treatment with exemestane or mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
- Another malignancy within 5 years prior to randomization.
- Radiotherapy within four weeks prior to randomization.
- Currently receiving hormone replacement therapy, unless discontinued prior to randomization.
- Symptomatic brain or other CNS metastases.
- Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in this study is progression-free survival (PFS), defined<br /><br>as the time from date of randomization to the date of first documented<br /><br>progression or death due to any cause. If a patient has not had an event, PFS<br /><br>will be censored at the date of last adequate tumor assessment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare the two treatment arms with respect to Overall Survival (OS).<br /><br>- To evaluate the two treatment arms with respect to<br /><br>o Overall response rate (ORR)<br /><br>o Time to deterioration of ECOG performance status<br /><br>o Safety<br /><br>o Changes in Quality of Life (QoL) scores over time<br /><br>o Clinical benefit rate (CBR)<br /><br>- To summarize time to response and duration of response in the two treatment<br /><br>arms.</p><br>