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

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 - PI3K pathway in pm breast cancer pts treated with everolimus and exemestane

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46855

Enrollment

175

Registered

2013-11-07

Start date

2014-03-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced metastatic breast cancer breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Progression Biomarker study	—

Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results