Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer - Full Text View

Sponsored by:	NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00255788

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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
Estimated Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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 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
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2
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
Investigator:	Karen A. Gelmon, MD	British Columbia Cancer Agency

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000450849, CAN-NCIC-IND163, NOVARTIS-CAN-NCIC-IND163
Study First Received:	November 18, 2005
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00255788 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage IV breast cancer
male breast cancer

Study placed in the following topic categories:

Everolimus
Immunologic Factors
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms

Breast Cancer, Male
Immunosuppressive Agents
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Everolimus
Neoplasms
Neoplasms by Site
Immunologic Factors
Skin Diseases

Physiological Effects of Drugs
Breast Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 02, 2009