Arthralgia, Musculoskeletal Complications, Pain, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Conditions
Brief summary
This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably
Detailed description
PRIMARY OBJECTIVES: I. To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment. SECONDARY OBJECTIVES: I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness. II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency. OUTLINE: Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
DRUGletrozole
Given PO
DIETARY_SUPPLEMENTcalcium carbonate
Given PO
OTHERlaboratory biomarker analysis
Optional correlative studies
DIETARY_SUPPLEMENTcalcium citrate
Given PO
DIETARY_SUPPLEMENTcalcium glucarate
Given PO
Given PO
DIETARY_SUPPLEMENTcholecalciferol
Given PO
PROCEDUREassessment of therapy complications
Ancillary studies
Correlative studies
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma * Patients must be prescribed letrozole for adjuvant breast cancer treatment * Prior adjuvant tamoxifen is permitted * Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab
Exclusion criteria
* Diagnosis of Stage IV breast carcinoma * Pre-existing myalgias, arthralgias and/or joint stiffness \>= Grade 1, as defined using CTEP CTC identified during baseline physical exam * Inability to understand or cooperate with study procedures * Receipt of investigational drug within 30 days before study entry * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Unwillingness to give informed consent * Unwillingness to participate or inability to comply with the protocol for the duration of the study * Patients with serum calcium \>= 14 mg/dL * Patients with renal dysfunction defined as glomerular filtration rate \<10ml/min calculated using Cockroft-Gault equation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness | Baseline and 1 month post vitamin D repletion | Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Letrozole Serum Levels Before and After Vitamin D Repletion | Baseline and 1 month post vitamin D repletion | Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Letrozole) Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole: Given PO
calcium carbonate: Given PO
laboratory biomarker analysis: Optional correlative studies
calcium citrate: Given PO
calcium glucarate: Given PO
calcium gluconate: Given PO
cholecalciferol: Given PO
assessment of therapy complications: Ancillary studies
musculoskeletal complications management/prevention: Correlative studies | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evaluable for joint aches | 7 |
| Overall Study | Vitamin D levels not evaluable | 8 |
Baseline characteristics
| Characteristic | Treatment (Letrozole) |
|---|---|
| Age, Continuous | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.
Time frame: Baseline and 1 month post vitamin D repletion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline | Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness | 12 Participants |
| Post Vitamin D Repletion (1 Month) | Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness | 1 Participants |
Secondary
Letrozole Serum Levels Before and After Vitamin D Repletion
Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
Time frame: Baseline and 1 month post vitamin D repletion
Population: Only considering those patients who were baseline vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Letrozole Serum Levels Before and After Vitamin D Repletion | 85 micro-grams/mL |
| Post Vitamin D Repletion (1 Month) | Letrozole Serum Levels Before and After Vitamin D Repletion | 70 micro-grams/mL |