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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

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ClinicalTrials.gov Identifier: NCT01088893
Recruitment Status : Unknown
Verified May 2012 by Organisation for Oncology and Translational Research.
Recruitment status was:  Recruiting
First Posted : March 17, 2010
Last Update Posted : May 24, 2012
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Everolimus Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. measure change of biomarkers in pre- and post- surgery samples [ Time Frame: baseline and 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088893


Contacts
Contact: Louis Chow, MD (852)28610286

Locations
China
Unimed Medical Institute Recruiting
Hong Kong, China
Contact: Louis Chow, MD    (852)28610286      
Sponsors and Collaborators
Organisation for Oncology and Translational Research
More Information

Responsible Party: Senior Manager, OOTR
ClinicalTrials.gov Identifier: NCT01088893     History of Changes
Other Study ID Numbers: OOTR-N006
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Organisation for Oncology and Translational Research:
everolimus
neoadjuvant
m-TOR inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents