Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

May 22, 2012 updated by: Organisation for Oncology and Translational Research

A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy

This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.

Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • China
      • Hong Kong, China
        • Recruiting
        • UNIMED Medical Institute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged ≥ 18 years;
  • Histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
  • Tumor of 3 cm or greater at time of diagnosis
  • Measurable primary tumor after neoadjuvant treatment before randomization
  • No prior chemotherapy for breast cancer;
  • ECOG performance status ≤1 or Karnofsky performace status ≥ 70%
  • Adequate liver/renal function
  • Able to swallow whole tablets.
  • Able to give written informed consent
  • Able to follow prescription instructions reasonably well

Exclusion Criteria:

  • Male patient
  • Prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
  • Distant metastasis, including skin involvement beyond the breast area
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

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
Experimental: Everolimus
Drug: Everolimus
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
No Intervention: observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measure change of biomarkers in pre- and post- surgery samples
Time Frame: baseline and 1 month
baseline and 1 month

Collaborators and Investigators

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

Sponsor

Organisation for Oncology and Translational Research

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

November 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OOTR-N006

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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