Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

Organisation for Oncology and Translational Research

Status and phase

Unknown

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01088893

OOTR-N006

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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