Status:
COMPLETED
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Breast Cancer
Eligibility:
All Genders
16-120 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of 2 different treatment schedules of everolimus, in terms of clinical/radiological response and early progression, in patients with recurrent or metasta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00255788
Start Date
May 10 2005
End Date
January 18 2011
Last Update
August 4 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
2
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2
3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
4
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2