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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 48
- 主要终点
- Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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. -
排除标准
- •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
研究组 & 干预措施
Letrozole
Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
干预措施: letrozole (Drug)
结局指标
主要结局
Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.
时间窗: End of Study (24 weeks)
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.
次要结局
- Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.(End of Study (24 weeks))
- Percentage of Participants Discontinuing, Irrespective of Cause(End of Study (24 weeks))
- Change in Brief Pain Inventory (BPI) Composite Score(Baseline, 24 weeks (End of Study))
- Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)(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)(Baseline, Visit 1 (24 weeks = End of Study))