Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00653718
Study type	Observational
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact
Status	Completed
Phase
Start date	May 2008
Completion date	December 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms