Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01088893
• Other study ID #: OOTR-N006
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2009
• Last updated: May 22, 2012
• Start date: November 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Organisation for Oncology and Translational Research
• Contact: Louis Chow, MD
• Phone: (852)28610286
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Everolimus
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery

Locations

Country	Name	City	State
China	Unimed Medical Institute	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Organisation for Oncology and Translational Research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure change of biomarkers in pre- and post- surgery samples		baseline and 1 month	No