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

August 21, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Montréal, Quebec, Canada, H2W 1T8
    - Centre Hospitalier de l'Université de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Early breast cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Musculoskeletal pain Time Frame: Every two weeks	Every two weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Lymphocyte gene expression profiling Time Frame: Every two weeks	Every two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

AstraZeneca

Investigators

Principal Investigator: André Robidoux, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria