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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00688909
First received: May 29, 2008
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: letrozole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients discontinuing due to grade 2 or higher arthralgia-myalgia. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to discontinuation due to grade 2 or higher arthralgia- myalgia. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients discontinuing, irrespective of cause. [ Time Frame: 6months ] [ Designated as safety issue: Yes ]

Enrollment: 261
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole
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
Drug: letrozole
2.5 mg daily by mouth for 6 months
Other Name: Femara

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688909

  Show 48 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00688909     History of Changes
Other Study ID Numbers: CFEM345DUS59
Study First Received: May 29, 2008
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
breast cancer
adjuvant treatment in post menopausal women
letrozole
arthralgia-myalgia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Anastrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 17, 2014