Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
This study has been completed.
Sponsor:
NCIC Clinical Trials Group
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00255788
First received: November 18, 2005
Last updated: January 18, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by NCIC Clinical Trials Group:
Primary Outcome Measures:
- Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks [ Designated as safety issue: No ]
- Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse event rates [ Designated as safety issue: Yes ]
- Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks [ Designated as safety issue: No ]
- Response duration by evaluation 4 weeks after response and then every 8 weeks [ Designated as safety issue: No ]
- Correlative assessment of response with molecular markers of mTor activity on archival tissue [ Designated as safety issue: No ]
- Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue [ Designated as safety issue: No ]
| Study Start Date: | January 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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 metastatic breast cancer.
Secondary
- Determine the time to progression and response duration in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral everolimus once daily on days 1-28.
- Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255788
Locations
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Fraser Valley Cancer Centre at British Columbia Cancer Agency | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
| Study Chair: | Susan Ellard, MD | British Columbia Cancer Agency - Centre for the Southern Interior |
| Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00255788 History of Changes |
| Other Study ID Numbers: | I163, CAN-NCIC-IND163, NOVARTIS-CAN-NCIC-IND163, CDR0000450849 |
| Study First Received: | November 18, 2005 |
| Last Updated: | January 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by NCIC Clinical Trials Group:
|
recurrent breast cancer stage IV breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013