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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Everolimus
Sponsored by
Organisation for Oncology and Translational Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring everolimus, neoadjuvant, m-TOR inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Unimed Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

observation

Everolimus

Arm Description

Outcomes

Primary Outcome Measures

measure change of biomarkers in pre- and post- surgery samples

Secondary Outcome Measures

Full Information

First Posted
August 11, 2009
Last Updated
May 22, 2012
Sponsor
Organisation for Oncology and Translational Research
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1. Study Identification

Unique Protocol Identification Number
NCT01088893
Brief Title
Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Organisation for Oncology and Translational Research

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
everolimus, neoadjuvant, m-TOR inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
observation
Arm Type
No Intervention
Arm Title
Everolimus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
Primary Outcome Measure Information:
Title
measure change of biomarkers in pre- and post- surgery samples
Time Frame
baseline and 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Chow, MD
Phone
(852)28610286
Facility Information:
Facility Name
Unimed Medical Institute
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Chow, MD
Phone
(852)28610286

12. IPD Sharing Statement

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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

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