Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

NCT ID: NCT01088893

Last Updated: 2012-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-03-31

Brief 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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Everolimus

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

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

Interventions

Everolimus

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organisation for Oncology and Translational Research

OTHER

Sponsor Role: lead

Responsible Party

OOTR

Locations

Unimed Medical Institute

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Louis Chow, MD

Role: CONTACT

(852)28610286

Facility Contacts

Louis Chow, MD

Role: primary

(852)28610286

Other Identifiers

OOTR-N006

Identifier Type: -

Identifier Source: org_study_id