Clinical trial · Interventional
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post Menopausal Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
| exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- everolimus + exemestane
- description
- Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
- interventionNames
- Drug: everolimus
- Drug: exemestane
Primary outcomes (1)
- measure
- Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
- timeFrame
- Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
- description
- Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. * Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer. * Disease refractory to non-steroidal aromatase inhibitors, defined as: * Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or * Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC). * Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment. * Patients must have had: * At least one lesion that could have been accurately measured in at least one dimension * 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or * Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above. * Adequate bone marrow, coagulation, liver and renal function. * ECOG performance status ≤ 2. Exclusion Criteria: * Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test. * Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites). * Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days. * Previous treatment with mTOR inhibitors. * Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin). * Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required. * Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A * History of brain or other CNS metastases, including leptomeningeal metastasis.
References
Publications (0)
Data not yet available