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Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer (REAL)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
letrozole
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring breast cancer, adjuvant treatment in post menopausal women, letrozole, arthralgia-myalgia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 chemotherapy.
    • 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

Sites / Locations

  • Clearview Cancer Center
  • Hematology Oncology Services of Arkansas
  • Grass Valley Hematology Oncology
  • Aptium Oncology - Comprehensive Cancer Care of the Desert
  • Bay Area Cancer Research Group
  • Front Range Specialist
  • Lynn Cancer Center
  • Florida Cancer Specialists
  • Memorial Cancer Center
  • Palm Beach Cancer Specialists
  • Northeast Georgia Cancer Care, LLC
  • Augusta Oncology
  • Oncology Specialist of North Georgia
  • The Cancer Instiute at Alexian Brothers
  • Evanston Northwestern Hospital
  • Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates
  • Cancer Care of Kansas
  • Kentuckiana Cancer Institute
  • Mercy Hospital
  • Mercey Hospital
  • Maryland Hematology Oncology Associates, PA
  • Suburban Hospital Cancer Program
  • Hematology Oncology Asssociates of Ohio & Michigan
  • Center for Cancer Care and Research
  • Ballas Cancer Center, LLC DBA - St Louis
  • Southeast Nebraska Hematology & Oncology Consultants
  • Trinitas Comprehensive Cancer Center
  • Hematology-Oncology Assoc of Northern New Jersey
  • Somerset Hematology & Oncology
  • Cooper University Hospital
  • Broom Oncology
  • Cancer Care of W. NC
  • Marion L. Shepard Cancer Center
  • Summa Health System
  • Mukesh Bhatt, MD, INC.
  • Berks Hematology Oncology
  • South Carolina Oncology Associates
  • The West Clinic
  • Tenessee Oncology
  • Coastal Bend Cancer Center
  • Center for Oncology Research and Treatment
  • Central Utah Clinic
  • Northern Utah Associates
  • Medical Oncology & Hematology Associates of Northern Virginia
  • Rockingham Memorial Hospital Regional Cancer Center
  • Peninsula Cancer Center
  • Green Bay Oncologist, St Vincent Hospital
  • Oncology Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Letrozole

Arm Description

Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.

Outcomes

Primary Outcome Measures

Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.

Secondary Outcome Measures

Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.
For patients who discontinued from the study due to either grade 2 or higher arthralgia-myalgia, the time to discontinuation was calculated as the duration between the Visit 1 date and the last dose date. If the last dose date was missing, the EOS date was used.
Percentage of Participants Discontinuing, Irrespective of Cause
The percentage of patients who discontinued from the study irrespective of the reasons.
Change in Brief Pain Inventory (BPI) Composite Score
The BPI is a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). It also queries the patient about pain relief, pain quality, and patient perception of the cause of pain. The BPI composite score was calculated based on questions 3 to 6 of the BPI Questionnaire (short form). First each question was scored from 0 (no pain) to 10 (pain as bad as you can imagine) and circled on the CRF. Then a composite score was calculated as the mean of the scores. If any answer was missing, the composite score was set to missing. Change in BPI composite score indicates the change from baseline at week 24.
Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)
The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The Stanford HAQ 20-item disability scale was utilized for scoring of the Disability Index. The items were first scored within each category with values 0 to 3 (0 = Without any difficulty, 1 = With some difficulty, 2 = With much difficulty, 3 = Unable to do). The score for the disability index was the mean of the eight category scores. If more than 2 of the 8 categories, or >25%, were missing, the scale was not scored. If ≤2 of the categories were missing, the sum of the categories was divided by the number of answered categories. Change in Disability Index indicates the change from baseline at week 24.
Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)
The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score indicates greater pain intensity. Change in pain as assessed by VAS indicates the change from baseline at week 24.

Full Information

First Posted
May 29, 2008
Last Updated
May 23, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00688909
Brief Title
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Acronym
REAL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, adjuvant treatment in post menopausal women, letrozole, arthralgia-myalgia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole
Arm Type
Experimental
Arm Description
Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
letrozole
Other Intervention Name(s)
Femara
Intervention Description
2.5 mg daily by mouth for 6 months
Primary Outcome Measure Information:
Title
Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
Description
The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.
Time Frame
End of Study (24 weeks)
Secondary Outcome Measure Information:
Title
Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.
Description
For patients who discontinued from the study due to either grade 2 or higher arthralgia-myalgia, the time to discontinuation was calculated as the duration between the Visit 1 date and the last dose date. If the last dose date was missing, the EOS date was used.
Time Frame
End of Study (24 weeks)
Title
Percentage of Participants Discontinuing, Irrespective of Cause
Description
The percentage of patients who discontinued from the study irrespective of the reasons.
Time Frame
End of Study (24 weeks)
Title
Change in Brief Pain Inventory (BPI) Composite Score
Description
The BPI is a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). It also queries the patient about pain relief, pain quality, and patient perception of the cause of pain. The BPI composite score was calculated based on questions 3 to 6 of the BPI Questionnaire (short form). First each question was scored from 0 (no pain) to 10 (pain as bad as you can imagine) and circled on the CRF. Then a composite score was calculated as the mean of the scores. If any answer was missing, the composite score was set to missing. Change in BPI composite score indicates the change from baseline at week 24.
Time Frame
Baseline, 24 weeks (End of Study)
Title
Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)
Description
The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The Stanford HAQ 20-item disability scale was utilized for scoring of the Disability Index. The items were first scored within each category with values 0 to 3 (0 = Without any difficulty, 1 = With some difficulty, 2 = With much difficulty, 3 = Unable to do). The score for the disability index was the mean of the eight category scores. If more than 2 of the 8 categories, or >25%, were missing, the scale was not scored. If ≤2 of the categories were missing, the sum of the categories was divided by the number of answered categories. Change in Disability Index indicates the change from baseline at week 24.
Time Frame
Baseline, Visit 1(24 weeks = End of Study)
Title
Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)
Description
The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score indicates greater pain intensity. Change in pain as assessed by VAS indicates the change from baseline at week 24.
Time Frame
Baseline, Visit 1 (24 weeks = End of Study)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 chemotherapy. 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. 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. Hormone receptor-positive tumors as defined by institutional standards. ECOG performance status of 0, 1, or 2 Consent to participate in the trial. - Exclusion Criteria: Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease. Recent history of pain associated with non-traumatic bone fracture. Pain requiring chronic use of analgesics (due to any reason). History of rheumatological disease except osteoarthritis. Prior hormonal therapy with AIs other than anastrozole. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream. Concomitant disease which significantly affects quality of life. Patient unable to complete self administered questionnaire. Patients unable to sign consent form. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clearview Cancer Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Hematology Oncology Services of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Grass Valley Hematology Oncology
City
Grass Valley
State/Province
California
ZIP/Postal Code
95945
Country
United States
Facility Name
Aptium Oncology - Comprehensive Cancer Care of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Front Range Specialist
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Lynn Cancer Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Memorial Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Palm Beach Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Augusta Oncology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Oncology Specialist of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
The Cancer Instiute at Alexian Brothers
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Evanston Northwestern Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Cancer Care of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Mercey Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Maryland Hematology Oncology Associates, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Suburban Hospital Cancer Program
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Hematology Oncology Asssociates of Ohio & Michigan
City
Lambertville
State/Province
Michigan
ZIP/Postal Code
48144
Country
United States
Facility Name
Center for Cancer Care and Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Ballas Cancer Center, LLC DBA - St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63414
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Trinitas Comprehensive Cancer Center
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07207
Country
United States
Facility Name
Hematology-Oncology Assoc of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Somerset Hematology & Oncology
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Cooper University Hospital
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Broom Oncology
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Cancer Care of W. NC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Marion L. Shepard Cancer Center
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Mukesh Bhatt, MD, INC.
City
Medina
State/Province
Ohio
ZIP/Postal Code
44256
Country
United States
Facility Name
Berks Hematology Oncology
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tenessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Center for Oncology Research and Treatment
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Central Utah Clinic
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Rockingham Memorial Hospital Regional Cancer Center
City
Harrisonburg
State/Province
Virginia
ZIP/Postal Code
22801
Country
United States
Facility Name
Peninsula Cancer Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Green Bay Oncologist, St Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Oncology Alliance
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3500
Description
Results for CFEM345DUS59 from the Novartis Clinical Trials Results Database

Learn more about this trial

Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

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