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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

This study is currently recruiting participants.
Verified May 2012 by Organisation for Oncology and Translational Research
Sponsor:
Information provided by:
Organisation for Oncology and Translational Research
ClinicalTrials.gov Identifier:
NCT01088893
First received: August 11, 2009
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasms
 Drug: Everolimus
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Organisation for Oncology and Translational Research:

Primary Outcome Measures:
  • measure change of biomarkers in pre- and post- surgery samples [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: observation
Experimental: Everolimus Drug: Everolimus
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Senior Manager, OOTR
ClinicalTrials.gov Identifier: NCT01088893     History of Changes
Other Study ID Numbers: OOTR-N006
Study First Received: August 11, 2009
Last Updated: May 22, 2012
Health Authority: Hong Kong: Department of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013