Breast CancerNCT03581552
Effects of Aromatase Inhibitor Therapy on Muscle Function
An observational study of Breast Cancer and Breast Cancer Female, run by Tarah J Ballinger, MD at 1 site in United States.
Trial summary
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 7 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Post menopausal women with non metastatic breast cancer planning to initiate aromatase inhibitor therapy at the IU Simon Cancer Center oncology clinic.
Who may be able to join
- Age ≥ 18 years
- 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
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- Must be willing to undergo muscle biopsy at baseline and after 24 weeks of AI therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of study enrollment
- Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
Who cannot join
- Unwilling to co-enroll into the FIT core study
- Diagnosis of severe osteopenia or osteoporosis, defined as a bone mineral density of ≥ 2.0 standard deviations below the young adult female reference mean (T score)
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Examining Molecular and Clinical Effects of Aromatase Inhibitor Therapy on Skeletal Muscle Function in Early Stage Breast Cancer
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- Post Menopausal, ER positive, Aromatase Inhibitor Therapy, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in calstabin1 binding to RyR1 channels in skeletal muscle
Changes in calstabin1 binding to RyR1 channels in skeletal muscle of breast cancer patients pre and post exposure to adjuvant aromatase inhibitor therapy
Measured: through day 168 of aromatase inhibitor therapy
Secondary outcomes (6)
Changes in ryanodine receptor/calcium release channel (RyR1) oxidation in skeletal muscle
To estimate changes in RyR1 oxidation in skeletal muscle of breast cancer patients, pre- and post- exposure to adjuvant aromatase inhibitor therapy
Measured: through day 168 of aromatase inhibitor therapy
Relationship between changes in RyR1 biochemistry and measures of muscle function
To explore the relationship between changes in RyR1 biochemistry and measures of muscle function, including muscle power as measured by isokinetic dynamometry
Measured: through day 168 of aromatase inhibitor therapy
Relationship between markers of bone turnover and changes in RyR1 biochemistry
To explore the relationship between markers of bone turnover and changes in RyR1 biochemistry (calstabin binding to RyR1)
Measured: through day 168 of aromatase inhibitor therapy
Relationship between markers of bone turnover and changes in muscle function
To explore the relationship between markers of bone turnover and changes in muscle function in terms of muscle power assessed by isokinetic dynamometry
Measured: through day 168 of aromatase inhibitor therapy
Characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy
To better characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy, in terms muscle power measured by isokinetic dynamometry
Measured: through day 168 of aromatase inhibitor therapy
Feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy
- To describe the feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy, in terms of rate of completion of baseline and follow up biopsy
Measured: through day 168 of aromatase inhibitor therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start26 Jul 2018
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarah J Ballinger, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581552
- Sponsor's protocol ID
- IUSCC-0647
- Status last verified
- May 2021
- First submitted
- 4 Jun 2018
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining Molecular and Clinical Effects of Aromatase Inhibitor Therapy on Skeletal Muscle Function in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT03581552
- Acronym / sponsor ID
- IUSCC-0647
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- Post Menopausal, ER positive, Aromatase Inhibitor Therapy, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tarah J Ballinger, MDUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post menopausal women with non metastatic breast cancer planning to initiate aromatase inhibitor therapy at the IU Simon Cancer Center oncology clinic.
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- 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.
Key exclusion criteria (9 listed)
- Unwilling to co-enroll into the FIT core study
- Diagnosis of severe osteopenia or osteoporosis, defined as a bone mineral density of ≥ 2.0 standard deviations below the young adult female reference mean (T score)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in calstabin1 binding to RyR1 channels in skeletal muscle
Time frame: through day 168 of aromatase inhibitor therapy
Changes in calstabin1 binding to RyR1 channels in skeletal muscle of breast cancer patients pre and post exposure to adjuvant aromatase inhibitor therapy
6 secondary outcomes
Changes in ryanodine receptor/calcium release channel (RyR1) oxidation in skeletal muscle
Time frame: through day 168 of aromatase inhibitor therapy
Relationship between changes in RyR1 biochemistry and measures of muscle function
Time frame: through day 168 of aromatase inhibitor therapy
Relationship between markers of bone turnover and changes in RyR1 biochemistry
Time frame: through day 168 of aromatase inhibitor therapy
Relationship between markers of bone turnover and changes in muscle function
Time frame: through day 168 of aromatase inhibitor therapy
Characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy
Time frame: through day 168 of aromatase inhibitor therapy
Feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy
Time frame: through day 168 of aromatase inhibitor therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarah Ballinger, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer Female, run by Tarah J Ballinger, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in calstabin1 binding to RyR1 channels in skeletal muscle (time frame: through day 168 of aromatase inhibitor therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.