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Completed

NCT Number: NCT00688909

Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clearview Cancer Center, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 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. -

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

Treatment and study plan

letrozole

Drug

2.5 mg daily by mouth for 6 months

Other names: Femara

Primary outcomes

  1. Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.

    Time frame: 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.

Secondary outcomes

  1. Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.

    Time frame: End of Study (24 weeks)

    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.

  2. Percentage of Participants Discontinuing, Irrespective of Cause

    Time frame: End of Study (24 weeks)

    The percentage of patients who discontinued from the study irrespective of the reasons.

  3. Change in Brief Pain Inventory (BPI) Composite Score

    Time frame: Baseline, 24 weeks (End of Study)

    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.

  4. Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, Visit 1(24 weeks = End of Study)

    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.

  5. Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, Visit 1 (24 weeks = End of Study)

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: REAL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2008
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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