Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
everolimus, neoadjuvant, m-TOR inhibitor
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Everolimus
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Unimed Medical Institute
Hong Kong, China
Status: Recruiting
Contact: Louis Chow, MD - (852)28610286
Start Date
November 2009
Completion Date
March 2013
Sponsors
Organisation for Oncology and Translational Research
Source
Organisation for Oncology and Translational Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page