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Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI therapy | Subjects who started treatment with any of the three aromatase inhibitor (AI) medications |
| |
| Tamoxifen | Subjects who started treatment with tamoxifen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anastrozole, letrozole, exemestane | Drug | Patients were treated with one of the listed anti-hormonal medications for up to one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy | Change in BMI between baseline and 12 months of endocrine therapy | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Medication on Change in Grip Strength | Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months | baseline and 12 months |
| Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen.
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| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry, MD, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AI Therapy | Subjects who started treatment with any of the three aromatase inhibitor (AI) medications |
| FG001 | Tamoxifen | Subjects who started treatment with tamoxifen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AI Therapy | Subjects who started treatment with any of the three aromatase inhibitor (AI) medications |
| BG001 | Tamoxifen | Subjects who started treatment with tamoxifen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy | Change in BMI between baseline and 12 months of endocrine therapy | These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded. | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 12 months |
|
12 months
only unexpected serious adverse events were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AI Therapy | Subjects who started treatment with any of the three aromatase inhibitor (AI) medications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment | one patient died during study participation of reasons unrelated to study participation or AI therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| symptom leading to treatment discontinuation | General disorders | Non-systematic Assessment | For expected toxicities, we only collected information about whether a patient felt her symptoms were bothersome enough to stop treatment, not treatment about the individual symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Norah Lynn Henry, MD | University of Michigan Comprehensive Cancer Center | 734-936-4991 | norahh@med.umich.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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Whole blood is being collected at baseline for DNA extraction. Serum is being collected at baseline and after 3, 6, and 12 months.
| Tamoxifen | Drug | Patients were treated with tamoxifen for up to one year |
|
|
Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment |
| baseline and 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body-mass index | Mean | Standard Deviation | kg/m^2 |
|
| Waist-hip ratio | Mean | Standard Deviation | ratio |
|
| Maximum grip strength, right hand | Mean | Standard Deviation | kPa |
|
| Maximum grip strength, left hand | Mean | Standard Deviation | kPa |
|
| Average pain | Patients reported pain on a 0-10 visual analog scale, with 0 being no pain and 10 being worst pain imaginable. | Mean | Standard Deviation | units on a scale |
|
Subjects who started treatment with tamoxifen |
|
|
|
| Secondary | Effect of Medication on Change in Grip Strength | Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months | Posted | Mean | Standard Deviation | percent change | baseline and 12 months |
|
|
|
|
| Secondary | Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months | Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment | Posted | Number | participants | baseline and 12 months |
|
|
|
|
| 1 |
| 93 |
| 37 |
| 93 |
| EG001 | Tamoxifen | Subjects who started treatment with tamoxifen | 0 | 22 | 2 | 22 |
|
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |