Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255788
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : November 28, 2016
Information provided by:
Canadian Cancer Trials Group

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 they work in treating patients with recurrent or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: everolimus Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
  2. Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

Secondary Outcome Measures :
  1. Adverse event rates
  2. Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
  3. Response duration by evaluation 4 weeks after response and then every 8 weeks
  4. Correlative assessment of response with molecular markers of mTor activity on archival tissue
  5. Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN


  • Creatinine ≤ 1.5 times ULN


  • 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



  • 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


  • 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


  • At least 3 weeks since prior major surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255788

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
Study Chair: Susan Ellard, MD British Columbia Cancer Agency - Centre for the Southern Interior
Study Chair: Karen A. Gelmon, MD British Columbia Cancer Agency

Publications: Identifier: NCT00255788     History of Changes
Other Study ID Numbers: I163
CDR0000450849 ( Other Identifier: PDQ )
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: January 2011

Keywords provided by Canadian Cancer Trials Group:
recurrent breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents