PI3K pathway analysis in tumor tissue and circulating DNA to obtain further insight in the efficacy of everolimus when combined with exemestane. A side-study protocol attached to standard treatment with everolimus and exemestane for postmenopausal patients with hormone receptor-positive advanced metastatic breast cancer, who have progressed on anastrozole or letrozole
- Conditions
- advanced metastatic breast cancerbreast cancer10006291
- Registration Number
- NL-OMON46855
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 175
1. Adult women (* 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
2. Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer.
3. Postmenopausal women.
4. Disease refractory to non steroidal aromatase inhibitors (NSAI).
1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
2. Previous treatment with mTOR inhibitors.
3. Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
4. Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression<br /><br>Biomarker study</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.v.t.</p><br>