Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study (AIMS)

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00653718
First received: April 2, 2008
Last updated: July 30, 2009
Last verified: September 2008
  Purpose

In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist activity, which is responsible for the drug's detrimental effects such as endometrial carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen. Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become the preferred therapy for post-menopausal woman.

However, AI therapy is also associated with toxicities that merit in-depth studies, one of them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of 5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with 21% in the placebo group following 5 to 6 years of tamoxifen 5.

Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based on the "Common Terminology Criteria for Adverse Events", which covers a wide range of symptoms and does not facilitate the documentation of a pain syndrome in a specific manner. Therefore, there is a need to design a study that will describe the nature of the pain associated with the administration of AI therapy using tools that have been validated for capturing a multidimensional phenomenon such as pain.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Musculoskeletal pain [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lymphocyte gene expression profiling [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Early breast cancer patients

Criteria

Inclusion Criteria:

  • Female
  • Invasive carcinoma of the breast confirmed by needle biopsy or final pathological evaluation of the surgical specimen
  • Breast cancer Stage I, II or IIIa
  • ER and/or PR+
  • No evidence of metastatic disease
  • Post-menopausal
  • May or may not have received adjuvant or neoadjuvant chemotherapy
  • Bilateral infiltrating carcinoma are eligible

Exclusion Criteria:

  • Men not eligible
  • Other malignancies
  • Patients who have received neoadjuvant or adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor
  • Ongoing treatment with any sex hormonal therapy (these patients are eligible if this therapy is discontinued prior to entry)
  • Therapy with hormonal agent such as raloxifene for osteoporosis
  • Patients receiving glucocorticoids
  • Psychiatric or addictive disorders
  • Inability to read English or French
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653718

Locations
Canada, Quebec
Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
AstraZeneca
Investigators
Principal Investigator: André Robidoux, MD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: André Robidoux MD, Centre hospitalier de l'Université de Montréal
ClinicalTrials.gov Identifier: NCT00653718     History of Changes
Other Study ID Numbers: D5390L00068
Study First Received: April 2, 2008
Last Updated: July 30, 2009
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Pain
Characterize musculoskeletal pain
Breast cancer patients treated with aromatase inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Musculoskeletal Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014