Clinical trial · Interventional
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
NCT00255788CI-TRIAL-00068545completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Everolimus - 28 days q 4 wk
- interventionNames
- Drug: everolimus
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Everolimus - days 1, 8, 15 and 22 q 4wks
- interventionNames
- Drug: everolimus
Primary outcomes (2)
- measure
- Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
- measure
- Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or recurrent disease * Considered incurable * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Two primary breast cancers allowed * Paraffin-embedded primary or metastatic tumor sample available * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active uncontrolled infection * No upper gastrointestinal condition or other condition that would preclude ability to take oral medication * No other serious medical condition that would preclude study participation * No psychiatric illness or neurologic disorder that would preclude study compliance * No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder PRIOR CONCURRENT THERAPY: Chemotherapy * At least 4 weeks since prior chemotherapy * Prior adjuvant chemotherapy allowed * No more than 1 prior chemotherapy regimen for metastatic or recurrent disease Endocrine therapy * At least 5 days since prior hormonal therapy Radiotherapy * At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction, palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to \< 20% of functioning bone marrow * If prior radiotherapy was to sole site of disease, must have subsequent documented disease progression at that site Surgery * At least 3 weeks since prior major surgery Other * Concurrent prophylactic bisphosphonates allowed, if started prior to study entry * No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem, or ketoconazole and similar antifungals * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent grapefruit juice
References
Publications (1)
- RESULTEllard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol. 2009 Sep 20;27(27):4536-41. doi: 10.1200/JCO.2008.21.3033. Epub 2009 Aug 17. PMID 19687332