Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 24, 2012
May 1, 2012
3.1 years
August 11, 2009
May 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measure change of biomarkers in pre- and post- surgery samples
baseline and 1 month
Study Arms (2)
observation
NO INTERVENTIONEverolimus
EXPERIMENTALInterventions
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unimed Medical Institute
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2009
First Posted
March 17, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
May 24, 2012
Record last verified: 2012-05