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Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Organisation for Oncology and Translational Research.
Recruitment status was  Recruiting
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

August 11, 2009
May 22, 2012
November 2009
December 2012   (final data collection date for primary outcome measure)
measure change of biomarkers in pre- and post- surgery samples [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01088893 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
Drug: Everolimus
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
  • No Intervention: observation
  • Experimental: Everolimus
    Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Louis Chow, MD (852)28610286
China
 
NCT01088893
OOTR-N006
Not Provided
Senior Manager, OOTR
Organisation for Oncology and Translational Research
Not Provided
Not Provided
Organisation for Oncology and Translational Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP