Phase 4
N=261
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00688909 ↗Enrolled (actual)
261
Serious AEs
1.9%
Results posted
May 2021
Primary outcome: Primary: Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia. — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- letrozole (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia. |
25 | — |
| SECONDARY Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia. |
156.98 | — |
| SECONDARY Percentage of Participants Discontinuing, Irrespective of Cause |
33 | — |
| SECONDARY Change in Brief Pain Inventory (BPI) Composite Score |
2.78; -0.46 | — |
| SECONDARY Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ) |
0.54; -0.07 | — |
| SECONDARY Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ) |
28.9; -6.4 | — |
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
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 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
Data sourced from ClinicalTrials.gov (NCT00688909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.