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Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
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
  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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014