Know Cancer

forgot password

Open Label, Multicenter Trial Of Femera (Letrozole) 2.5 mg As First-line Therapy In Postmenopausal Women With Metastatic Breast Cancer Relapsing Following Adjuvant Tamoxifen Therapy

Phase 4
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Open Label, Multicenter Trial Of Femera (Letrozole) 2.5 mg As First-line Therapy In Postmenopausal Women With Metastatic Breast Cancer Relapsing Following Adjuvant Tamoxifen Therapy

OBJECTIVES: I. Determine the time to progression of postmenopausal women with metastatic
breast cancer treated with letrozole (Femara) as first-line therapy. II. Determine the
objective response rate, time to treatment failure, survival rate, and changes in symptom
distress in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to time to diagnosis
of metastatic disease. Patients receive oral letrozole (Femara) daily. Treatment continues
in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Measurable or evaluable
disease Postmenopausal No spontaneous menses for at least 5 years (including
chemotherapy-induced amenorrhea) Spontaneous menses within the past 5 years allowed if
amenorrheic for at least 12 months and LH and FSH in postmenopausal normal range
(including chemotherapy-induced amenorrhea) Bilateral oophorectomy Radiotherapy castration
and amenorrheic for at least 3 months Hormone receptor status: Estrogen-receptor (ER)
and/or progesterone-receptor (PR) positive No ER and PR negative or unknown tumors

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: See Disease
Characteristics Performance status: Karnofsky 50-100% WHO 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Corrected serum
calcium less than 11.6 mg/dL Other: No known hypersensitivity to any of the constituents
of the study drug No history of noncompliance to medical regimens No unreliability Not
pregnant or nursing Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy or
biological response modifiers Chemotherapy: See Disease Characteristics Prior adjuvant or
neoadjuvant chemotherapy with adjuvant tamoxifen allowed No concurrent anticancer
chemotherapy Endocrine therapy: See Chemotherapy No other concurrent anticancer endocrine
therapy (including steroids) Radiotherapy: See Disease Characteristics No concurrent
radiotherapy to sole site of disease Concurrent radiotherapy to a limited area (e.g., for
painful disease) allowed Surgery: See Disease Characteristics No prior adrenalectomy or
hypophysectomy Other: At least 30 days since prior systemic investigational drugs At least
7 days since prior topical investigational drugs No other concurrent investigational drugs
Concurrent bisphosphonates (e.g., zoledronic acid) for bone metastasis allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephanie Petrone, SCRS

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

January 2001

Completion Date:

March 2002

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Good Samaritan Medical Center West Palm Beach, Florida  33401
Oncology-Hematology Group of South Florida Miami, Florida  33176
Long Beach Memorial Breast Center Long Beach, California  90806
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
New Mexico Oncology-Hematology Albuquerque, New Mexico  87102
Joliet Oncology/Hematology Associates, Ltd. Joliet, Illinois  60435
Carle Cancer Center Urbana, Illinois  61801
Cancer Research Network Inc. Plantation, Florida  33324
Memorial Medical Center Springfield, Illinois  62781
Cancer Research Network, Inc. Plantation, Florida  33324
Dial Research Associates, Inc. Nashville, Tennessee  37205
Center for Oncology Research and Treatment, Medical City Hospital Dallas, Texas  75230
Memphis Cancer Center Memphis, Tennessee  38119
Intermountain Hematology/Oncology Associates, Inc. Salt Lake City, Utah  84124
Pharm Research Pinecrest, Florida  33156
Illinois Oncology, Ltd. Belleville, Illinois  62221
Southwest Oncology Association Lafayette, Louisiana  70503
Oncology Partnership Network Cincinnati, Ohio  45238
Cascade Cancer Center Kirkland, Washington  98034-3013