A Phase 4 interventional study of letrozole in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 48 sites in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Other
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 261 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
Drug: letrozole
2.5 mg daily by mouth for 6 months
Also known as: Femara
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.
Time frame: End of Study (24 weeks)
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.
Time frame: End of Study (24 weeks)
Percentage of Participants Discontinuing, Irrespective of Cause
The percentage of patients who discontinued from the study irrespective of the reasons.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Visit 1 (24 weeks = End of Study)
The study enrolled 261 participants at 45 centers in United States.
| Milestone | Letrozole |
|---|---|
| Started | 261 |
| Completed | 228 |
| Not completed | 33 |
| Withdrew: Adverse event | 28 |
| Withdrew: Patient withdrew consent | 2 |
| Withdrew: Administrative problems | 1 |
| Withdrew: Protocol violation | 2 |
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.
| Participants | Letrozole |
|---|---|
| Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia. | 25 |
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.
| days | Letrozole |
|---|---|
| Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia. | 156.98 ± 1.94 |
The percentage of patients who discontinued from the study irrespective of the reasons.
| Participants | Letrozole |
|---|---|
| Percentage of Participants Discontinuing, Irrespective of Cause | 33 |
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.
| score on a scale | Letrozole |
|---|---|
| Baseline visit | 2.78 ± 2.00 |
| Week 24 | -0.46 ± 2.09 |
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.
| score on a scale | Letrozole |
|---|---|
| Visit 1 (Baseline visit) | 0.54 ± 0.55 |
| Visit 4 (Week 24) | -0.07 ± 0.47 |
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.
| score on a scale | Letrozole |
|---|---|
| Visit 1 (Baseline visit) | 28.9 ± 24.22 |
| Visit 4 (Week 24) | -6.4 ± 29.30 |
Collected over Adverse events were collected From Start of the Study up to EOS (Week 24). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letrozole 2.5 mg | 0/261 (0%) | 5/261 (1.9%) | 163/261 (62.5%) |
| Event | Letrozole 2.5 mg |
|---|---|
| Cholecystitis chronicHepatobiliary disorders | 1/261 |
| Post procedural bile leakInjury, poisoning and procedural complications | 1/261 |
| Spinal column stenosisMusculoskeletal and connective tissue disorders | 1/261 |
| DepressionPsychiatric disorders | 1/261 |
| ManiaPsychiatric disorders | 1/261 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/261 |
| Event | Letrozole 2.5 mg |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 88/261 |
| MyalgiaMusculoskeletal and connective tissue disorders | 78/261 |
| Hot flushVascular disorders | 37/261 |
| FatigueGeneral disorders | 32/261 |
| NauseaGastrointestinal disorders | 13/261 |
| DepressionPsychiatric disorders | 13/261 |
| Oedema peripheralGeneral disorders | 10/261 |
| ConstipationGastrointestinal disorders | 8/261 |
| DiarrhoeaGastrointestinal disorders | 8/261 |
| HeadacheNervous system disorders | 8/261 |
| Age, Continuous(years) | Letrozole |
|---|---|
| Mean | 61.6 ± 10.2 |
| Sex/Gender, Customized(Participants) | Letrozole |
|---|---|
| Female | 261 |
| Race/Ethnicity, Customized(Participants) | Letrozole |
|---|---|
| Caucasian | 235 |
| Black | 14 |
| Asian | 3 |
| Other | 9 |
| Relevant Medical and Surgical History(Participants) | Letrozole |
|---|---|
| Yes | 261 |
| No | 0 |
| Rheumatology History(Participants) | Letrozole |
|---|---|
| Yes | 261 |
| No | 0 |
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