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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Experimental | Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letrozole | Drug | 2.5 mg daily by mouth for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of Study (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of Study (24 weeks) |
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Inclusion Criteria:
Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:
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:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Center | Huntsville | Alabama | 35805 | United States | ||
| Hematology Oncology Services of Arkansas |
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| Label | URL |
|---|---|
| Results for CFEM345DUS59 from the Novartis Clinical Trials Results Database | View source |
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It was estimated it would be necessary to enroll 228 patients so that the percentage of patients discontinuing due to arthralgia-myalgias would be 50%, within 6.5% of the true percentage with 95% confidence.
The study enrolled 261 participants at 45 centers in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Letrozole | Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants Discontinuing, Irrespective of Cause | The percentage of patients who discontinued from the study irrespective of the reasons. | End of Study (24 weeks) |
| 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. | Baseline, 24 weeks (End of Study) |
| 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. | Baseline, Visit 1(24 weeks = End of Study) |
| 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. | Baseline, Visit 1 (24 weeks = End of Study) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Grass Valley Hematology Oncology | Grass Valley | California | 95945 | United States |
| Aptium Oncology - Comprehensive Cancer Care of the Desert | Palm Springs | California | 92262 | United States |
| Bay Area Cancer Research Group | Pleasant Hill | California | 94523 | United States |
| Front Range Specialist | Fort Collins | Colorado | 80528 | United States |
| Lynn Cancer Center | Boca Raton | Florida | 33428 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Memorial Cancer Center | Hollywood | Florida | 33021 | United States |
| Palm Beach Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Northeast Georgia Cancer Care, LLC | Athens | Georgia | 30607 | United States |
| Augusta Oncology | Augusta | Georgia | 30901 | United States |
| Oncology Specialist of North Georgia | Gainesville | Georgia | 30501 | United States |
| The Cancer Instiute at Alexian Brothers | Elk Grove Village | Illinois | 60007 | United States |
| Evanston Northwestern Hospital | Evanston | Illinois | 60201 | United States |
| Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates | Skokie | Illinois | 60076 | United States |
| Cancer Care of Kansas | Wichita | Kansas | 67214 | United States |
| Kentuckiana Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Mercy Hospital | Portland | Maine | 04101 | United States |
| Mercey Hospital | Baltimore | Maryland | 21202 | United States |
| Maryland Hematology Oncology Associates, PA | Baltimore | Maryland | 21237 | United States |
| Suburban Hospital Cancer Program | Bethesda | Maryland | 20817 | United States |
| Hematology Oncology Asssociates of Ohio & Michigan | Lambertville | Michigan | 48144 | United States |
| Center for Cancer Care and Research | St Louis | Missouri | 63141 | United States |
| Ballas Cancer Center, LLC DBA - St Louis | St Louis | Missouri | 63414 | United States |
| Southeast Nebraska Hematology & Oncology Consultants | Lincoln | Nebraska | 68516 | United States |
| Trinitas Comprehensive Cancer Center | Elizabeth | New Jersey | 07207 | United States |
| Hematology-Oncology Assoc of Northern New Jersey | Morristown | New Jersey | 07962 | United States |
| Somerset Hematology & Oncology | Somerville | New Jersey | 08876 | United States |
| Cooper University Hospital | Voorhees Township | New Jersey | 08043 | United States |
| Broom Oncology | Binghamton | New York | 13905 | United States |
| Cancer Care of W. NC | Asheville | North Carolina | 28801 | United States |
| Marion L. Shepard Cancer Center | Washington | North Carolina | 27889 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Mukesh Bhatt, MD, INC. | Medina | Ohio | 44256 | United States |
| Berks Hematology Oncology | West Reading | Pennsylvania | 19611 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| The West Clinic | Memphis | Tennessee | 38138 | United States |
| Tenessee Oncology | Nashville | Tennessee | 37203 | United States |
| Coastal Bend Cancer Center | Corpus Christi | Texas | 78404 | United States |
| Center for Oncology Research and Treatment | Dallas | Texas | 75230 | United States |
| Central Utah Clinic | American Fork | Utah | 84003 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Medical Oncology & Hematology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States |
| Rockingham Memorial Hospital Regional Cancer Center | Harrisonburg | Virginia | 22801 | United States |
| Peninsula Cancer Center | Newport News | Virginia | 23601 | United States |
| Green Bay Oncologist, St Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Oncology Alliance | Wauwatosa | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Letrozole | Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Relevant Medical and Surgical History | Count of Participants | Participants |
| |||||||||||||||||||||||
| Rheumatology History | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety set: All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | End of Study (24 weeks) |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety set: All participants who received at least one dose of study drug. | Posted | Mean | Standard Error | days | End of Study (24 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Discontinuing, Irrespective of Cause | The percentage of patients who discontinued from the study irrespective of the reasons. | Safety set: All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | End of Study (24 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Safety set: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks (End of Study) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety set: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Visit 1(24 weeks = End of Study) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety set: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Visit 1 (24 weeks = End of Study) |
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Adverse events were collected From Start of the Study up to EOS (Week 24)
Safety set: All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Letrozole 2.5 mg | Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. | 0 | 261 | 5 | 261 | 163 | 261 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
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