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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Organisation for Oncology and Translational Research.
Recruitment status was:  Recruiting
Information provided by:
Organisation for Oncology and Translational Research Identifier:
First received: August 11, 2009
Last updated: May 22, 2012
Last verified: May 2012

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: 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

Resource links provided by NLM:

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 ]

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01088893

Contact: Louis Chow, MD (852)28610286

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 Identifier: NCT01088893     History of Changes
Other Study ID Numbers: OOTR-N006
Study First Received: August 11, 2009
Last Updated: May 22, 2012

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on September 19, 2017