A pilot study examining molecular and clinical effects of aromatase inhibitor therapy on skeletal muscle function in early stage breast cancer

T
Tarah Ballinger, MD

Primary Investigator

Overview

This research is being done to study how a type of breast cancer medicine called aromatase inhibitors (AI) affect muscle function in patients with breast cancer

Description

The purpose of this study is to learn more about the effects that aromatase inhibitors have on muscle function in patients with breast cancer.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    breast cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria
Post-menopausal
Diagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III ER positive breast cancer
Plan to initiate an AI per treating physician Completion of all primary therapy for breast cancer, including surgery, radiation, and chemotherapy (should be completed 14 days or more prior to obtaining the baseline muscle biopsy). Ongoing HER2 targeted therapy with trastuzumab and/or pertuzumab is allowed. Ongoing neratinib therapy is not allowed.
Body weight less than 350 lbs., as dictated by the weight limit for DXA (dual energy x-ray absorptiometry) scanner
Must be willing to undergo muscle biopsy at baseline and after 24 weeks of AI therapy
Exclusion Criteria
Unwilling to co-enroll into the FIT core study
Diagnosis of severe osteopenia or osteoporosis
Diagnosis of other disorder affecting bone function or turnover, such as Paget's disease, renal osteodystrophy, parathyroid disorders, or vitamin D deficiency/osteomalacia
Prior history of non-traumatic, fragility bone fracture
Any muscle or neuromuscular disorder affecting muscle function, such as muscular dystrophy, myositis, or amyotrophic lateral sclerosis
Any condition precluding power protocol participation (i.e. exertion on a stationary bicycle), including: New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator
Need for daily anticoagulation use
Allergy to local anesthetic
Locally recurrent or metastatic breast cancer a. History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable.


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022. Study ID: 1801852430 (IUSCC-0647)

Interested in the study?

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