Clinical trial · Interventional
Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery
A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
NCT00855114CI-TRIAL-00030621withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to no accrual
Summary
Brief summary (as posted)
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients Treated with Everolimus
- description
- Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.
- interventionNames
- Drug: everolimus
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Decrease of total choline in at least 30% of patients
- timeFrame
- Pre-Treatment Compared to Post-Treatment (Day 7)
- description
- Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
Secondary outcomes (1)
- measure
- Identification of response to everolimus by activated mTOR signaling
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of invasive breast cancer * Resectable disease * Measurable disease, defined as a primary breast mass \> 2.0 cm by breast imaging or clinical exam * Planning to undergo surgical resection after neoadjuvant therapy * Menopausal status not specified * Eastern Clinical Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 9.0 g/dL * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * Total bilirubin ≤ 1.5 times ULN * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception Exclusion Criteria: * Intracranial disease * Hormone receptor status not specified * Obese (\> 250 pounds) * Immunosuppression from any cause (e.g., known HIV infection) * History of severe asthma and/or allergies * History of severe claustrophobia * Ferromagnetic implants, history of shotgun wound and/or shrapnel, cardiac pacemakers, or other similar situations that would be contrary to strong magnetic force * Bleeding diathesis * Unstable systemic disease, including but not limited to, any of the following: * Uncontrolled diabetes * Severe infection * Severe malnutrition * Uncontrolled hypertension * Unstable angina * Ventricular arrhythmias * Active ischemic heart disease * Congestive heart failure * Myocardial infarction within the past 6 months * Chronic liver disease * Renal disease * Active upper gastrointestinal tract ulceration * Less than 4 weeks since prior investigational drug * Prior therapy with sirolimus or its analogues * Concurrent immunosuppressive therapy (e.g., steroids, cytotoxic agents, or concurrent radiotherapy) * Concurrent anticoagulation (i.e., coumadin)
References
Publications (0)
Data not yet available
No reference posted for this study.