Know Cancer

forgot password

Open-label, Single-arm, Multicenter Study to Evaluate the Rheumatological Tolerability of Letrozole as an Adjuvant Breast Cancer Treatment in Postmenopausal Women Who Are Intolerant and Discontinue Anastrozole Due to Grade 2-3 Arthralgia-myalgia

Phase 4
50 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Open-label, Single-arm, Multicenter Study to Evaluate the Rheumatological Tolerability of Letrozole as an Adjuvant Breast Cancer Treatment in Postmenopausal Women Who Are Intolerant and Discontinue Anastrozole Due to Grade 2-3 Arthralgia-myalgia

This is a multi-center prospective non-randomized single arm, open label trial in
postmenopausal HR positive early breast cancer patients who experience grade 2-3
arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole.
After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will
initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a
patient has breast cancer recurrence or is intolerant to letrozole during the 24 week
period, the drug will be discontinued.

Inclusion Criteria:

1. Postmenopausal women with HR+ early stage breast cancer at the time of initial
diagnosis. For study purposes, postmenopausal is defined as:

- Age ≥ 50 y and amenorrheic for 12 or more months.

- Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant

- Age < 50 y and amenorrheic for 12 or more months.

- Prior bilateral oophorectomy.

- Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as
per local institutional standards.

- Age > 55 y and prior hysterectomy.

2. Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study
entry when given as adjuvant treatment for HR+ early stage breast cancer due to
grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.

3. Hormone receptor-positive tumors as defined by institutional standards.

4. ECOG performance status of 0, 1, or 2

5. Consent to participate in the trial. -

Exclusion Criteria:

1. Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding
chest wall recurrence with no evidence of systemic disease.

2. Recent history of pain associated with non-traumatic bone fracture.

3. Pain requiring chronic use of analgesics (due to any reason).

4. History of rheumatological disease except osteoarthritis.

5. Prior hormonal therapy with AIs other than anastrozole.

6. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other
than Estring®, Vagifem® or low dose estrogen vaginal cream.

7. Concomitant disease which significantly affects quality of life.

8. Patient unable to complete self administered questionnaire.

9. Patients unable to sign consent form.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Proportion of patients discontinuing due to grade 2 or higher arthralgia-myalgia.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • adjuvant treatment in post menopausal women
  • letrozole
  • arthralgia-myalgia
  • Breast Neoplasms



Cooper University Hospital Camden, New Jersey  08103
Summa Health System Akron, Ohio  44312
Florida Cancer Specialists Fort Myers, Florida  33901
Center for Cancer Care and Research St. Louis, Missouri  63141
South Carolina Oncology Associates Columbia, South Carolina  29201
Kentuckiana Cancer Institute Louisville, Kentucky  40202
Hematology Oncology Services of Arkansas Little Rock, Arkansas  72205
Suburban Hospital Cancer Program Bethesda, Maryland  20817
Center for Oncology Research and Treatment Dallas, Texas  75230
Northern Utah Associates Ogden, Utah  84403
Northeast Georgia Cancer Care, LLC Athens, Georgia  30607
Bay Area Cancer Research Group Concord, California  94520
The West Clinic Memphis, Tennessee  38120
Mercy Hospital Portland, Maine  04101
Coastal Bend Cancer Center Corpus Christi, Texas  78404
Oncology Alliance Milwaukee, Wisconsin  53215
Cancer Care of Kansas Wichita, Kansas  67214
Marion L. Shepard Cancer Center Washington, North Carolina  
Peninsula Cancer Center Newport News, Virginia  23601
Clearview Cancer Center Huntsville, Alabama  35801
Trinitas Comprehensive Cancer Center Elizabeth, New Jersey  07207
Somerset Hematology & Oncology Somerville, New Jersey  08876
Central Utah Clinic Provo, Utah  84003
Rockingham Memorial Hospital Regional Cancer Center Harrisonburg, Virginia  22801
Medical Oncology & Hematology Associates of Northern Virginia Fairfax, Virginia  22031
Grass Valley Hematology Oncology Grass Valley, California  95945
Aptium Oncology - Comprehensive Cancer Care of the Desert Palm Springs, California  92262
Front Range Specialist Fort Collins, Colorado  80528
Lynn Cancer Center Boca Raton, Florida  33428
Memorial Cancer Center Hollywood, Florida  33021
Palm Beach Cancer Specialists West Palm Beach, Florida  33401
Augusta Oncology Augusta, Georgia  30901
Oncology Specialist of North Georgia Gainesville, Georgia  30501
The Cancer Instiute at Alexian Brothers Elk Grove Village, Illinois  60007
Evanston Northwestern Hospital Evanston, Illinois  60201
Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates Skokie, Illinois  60076
Maryland Hematology Oncology Associates, PA Baltimore, Maryland  21237
Mercey Hospital Baltimore, Maryland  21202
Hematology Oncology Asssociates of Ohio & Michigan Lambertville, Michigan  48144
Ballas Cancer Center, LLC DBA - St Louis St. Louis, Missouri  63414
Southeast Nebraska Hematology & Oncology Consultants Lincoln, Nebraska  68516
Hematology-Oncology Assoc of Northern New Jersey Morristown, New Jersey  07962
Broom Oncology Binghamton, New York  13905
Cancer Care of W. NC Ashville, North Carolina  28801
Mukesh Bhatt, MD, INC. Medina, Ohio  44256
Berks Hematology Oncology West Reading, Pennsylvania  19611
Tenessee Oncology Nashville, Tennessee  37203
Green Bay Oncologist, St Vincent Hospital Green Bay, Wisconsin  54301