Clinical trial · Interventional
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
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
NCT00688909CI-TRIAL-00052171REALcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole
- description
- Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
- interventionNames
- Drug: letrozole
Primary outcomes (1)
- measure
- Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
- timeFrame
- End of Study (24 weeks)
- 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.
Secondary outcomes (5)
- measure
- Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.