Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

August 3, 2023 updated by: NCIC Clinical Trials Group

A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Fraser Valley Cancer Centre at British Columbia Cancer Agency
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Everolimus - 28 days q 4 wk
Drug: everolimus
Active Comparator: Arm B
Everolimus - days 1, 8, 15 and 22 q 4wks
Drug: everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2005

Primary Completion (Actual)

July 22, 2008

Study Completion (Actual)

January 18, 2011

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimated)

November 21, 2005

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I163
  • CAN-NCIC-IND163 (Other Identifier: PDQ)
  • NOVARTIS-CAN-NCIC-IND163 (Other Identifier: Novartis)
  • CDR0000450849 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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