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A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasm

Thank you

Trial Information

A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women


Inclusion Criteria:



- Histologically-confirmed diagnosis of invasive breast cancer, previously untreated

- Patients must be postmenopausal

- Candidates for mastectomy or breast-conserving surgery

- Primary tumor of above 2 cm diameter, measured by imaging

- Clinical Stage M0

- WHO performance status ≤1

- Adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Multicentric invasive tumors

- Bilateral or inflammatory breast cancer

- Receiving concomitant anti-cancer treatments such as chemotherapy

- Patients with an uncontrolled infection

- Patients with other concurrent severe and/or uncontrolled medical disease

Additional protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2222

NCT ID:

NCT00107016

Start Date:

March 2005

Completion Date:

April 2007

Related Keywords:

  • Breast Neoplasm
  • Breast Cancer
  • Cancer of the Breast
  • Neo-adjuvant
  • Primary breast cancer
  • postmenopausal
  • pre-operative
  • Breast Neoplasms
  • Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Loyola University Medical CenterMaywood, Illinois  60153
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Highlands Oncology GroupSpringdale, Arkansas  72764
University of MiamiMiami, Florida  33136
Breastlink Medical Group Inc.Long Beach, California  90806
UCSF Breast Care CenterSan Francisco, California  94115
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
UPMC / Magee Womens HospitalPittsburgh, Pennsylvania  15213