CLINICAL TRIAL

pharmacological study for Breast Cancer

Waitlist Available · 18+ · Female · Minneapolis, MN

This study is evaluating whether a low dose of tamoxifen citrate can reduce the risk of breast cancer in women who have been treated with radiation for cancer.

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About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. Pharmacological Study is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
pharmacogenomic studies
OTHER
Digital mammography
PROCEDURE
immunohistochemistry staining method
OTHER
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
protein expression analysis
GENETIC
Quality of Life Assessment
OTHER
questionnaire administration
OTHER
Fine needle aspiration
PROCEDURE
Tamoxifen Citrate
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
pharmacogenomic studies
OTHER
Digital mammography
PROCEDURE
immunohistochemistry staining method
OTHER
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
protein expression analysis
GENETIC
Quality of Life Assessment
OTHER
questionnaire administration
OTHER
Fine needle aspiration
PROCEDURE
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital mammography
2016
N/A
~29460
protein expression analysis
2008
Completed Phase 2
~1100
Fine needle aspiration
2015
N/A
~290
Tamoxifen
FDA approved

Eligibility

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No evidence of active disease from their primary cancer for at least 2 continuous years prior to registration; the indication for RT is not specified but cannot be for primary breast cancer; common examples include, but are not limited to: lymphoma, leukemia, sarcoma, and Wilms tumor occurring in pediatric patients, and lymphoma, leukemia, and sarcoma occurring in young adults; primary cancer therapy must have been completed at least 6 months prior to registration
Exposure to radiation therapy (RT) delivered to the chest, axilla, and/or supraclavicular areas at a cumulative dose of 12 Gy or more by age 40 years; in addition, patients who received total body irradiation by age 40 may be considered
Postmenopausal, defined as continuous absence of menstruation for 12 months OR status-post bilateral oophorectomy OR follicle stimulating hormone (FSH) level in the postmenopausal range
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether pharmacological study will improve 1 primary outcome and 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 2 years.

Insulin Growth Factor Levels (IGF3 )
UP TO 2 YEARS
IGF3 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed.
Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire
UP TO 2 YEARS
The outcomes will be scored as a 5-point Likert-type scale (0-4) in response to questions on how much the patients are bothered by certain symptoms. The questionnaire will be administered every 6 months. The responses will be treated as normally distributed, as ordinal or dichotomized variable, and the linear mixed effects of general linear mixed model (GLMM) methods will be applied to compare changes between treatment groups. Piecewise models will also be fitted with join point at 6 months, considering linear and curvilinear trajectories between 6 and 24 month time points.
Mammographic Breast Density
AT YEAR TWO POST TREATMENT
Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data.
Biomarker Levels
UP TO 2 YEARS
Total cholesterol, low and high density lipoprotein, triglycerides, and anti-thrombin III enzymatic assay measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.
Biomarker Levels - Alkaline Phosphatase
UP TO 2 YEARS
Serum bone-specific alkaline phosphatase measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.
Number of Grade 2-4 Toxicities
UP TO 2 YEARS
Will be tabulated by treatment arm. Differences by treatment arm will be evaluated using Fisher exact tests.
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Who is running the study

Principal Investigator
S. B.
Smitia Bhatia, Principal Investigator
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can breast cancer be cured?

The majority of patients diagnosed with breast cancer can expect a five to 10-year survival following curative surgery. Most (95%) will have positive sentinel nodes. This should reassure patients as to their outcome, and the choice of treatment is based on local extent of the disease.

Anonymous Patient Answer

What are common treatments for breast cancer?

Some breast cancers are very aggressive and can be addressed with multimodal therapy. Others are more easily treated with surgery and may be treated with radiotherapy, chemotherapy or hormonal therapy. The best approach is highly individualized and tailored to the particular patient.

Anonymous Patient Answer

What causes breast cancer?

In Europe, it is estimated that 30,000 to 50,000 women will be diagnosed with breast cancer in the UK in 2020, many of whom will receive the BRCA1 or BRCA2 mutations.

Anonymous Patient Answer

What are the signs of breast cancer?

Certain signs and symptoms are indicative of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and can be helpful when taking a breast history. Signs and symptoms of breast cancer commonly include lumpiness, breast pain, a change of sensation, a lump, breast masses, a lumpy, painful breast, redness of the breasts, nipple pain or changes in the size or shape of the breasts. It is also helpful to take into account age, weight, diet as well as family history of breast cancer.

Anonymous Patient Answer

What is breast cancer?

Breast cancer forms as an abnormal growth of cells in the breast tissue. It typically takes place in older women, but breast cancer can arise at any age. Diagnosis and treatment options depend on which part of the breast is affected. A cancer of the nipple or an area around the nipple may not spread to other parts of the breast. Breast cancer can be benign or malignant and is often highly treatable.

Anonymous Patient Answer

Has pharmacological study proven to be more effective than a placebo?

A statistically significant effect was observed in the group treated with Arakon, suggesting the potential use of Arakon as a nootropic in clinical trials of Alzheimer's disease.

Anonymous Patient Answer

Does pharmacological study improve quality of life for those with breast cancer?

Findings from a recent study demonstrate that the treatment and care of patients with breast cancer results in significant improvement in these patients' mental health. Further study is necessary to test whether this improvement is maintained over time, since these results illustrate that patient care also improves their perceptions of quality of care, their levels of optimism, and their satisfaction with care. Thus, the improvement in quality of life and psychological wellbeing may translate into sustained improvement in their overall well-being.

Anonymous Patient Answer

What is the average age someone gets breast cancer?

In a country like the U.S. that has a large immigrant population, the average age of breast cancer at diagnosis in the U.S. would probably be higher than the reported average of 65 (the average age of diagnosis for the whole adult population of the U.S.). However, the rate per 100,000 woman-years was lowest for age range 20-49. Given these numbers, mammography screening is the most cost- efficient way to screen mammograms.

Anonymous Patient Answer

What is the survival rate for breast cancer?

Patients with stage 4 breast cancer in the modern era with estrogen receptor-positive disease, who underwent first-line chemotherapy, had a better prognosis than patients who underwent the same therapy in the past, but also experienced mortality due to breast cancer when compared to those patients who did not receive chemotherapy.

Anonymous Patient Answer

What are the chances of developing breast cancer?

According to our models, the chances of developing cancer of the breast are 0.8% in healthy women aged 55 (for ER-positive breast cancer) and 1.1% in healthy women aged 65 (for ER-negative breast cancer). These estimates do not necessarily mean that women will get breast cancer, but rather that they would face a 1.2% chance of having it by the age of 65. The probabilities of developing cancer of the breast are 2.5% in this age group of women with the highest risk factors, such as being overweight, consuming tobacco, drink alcohol, and a history of prior breast cancer.

Anonymous Patient Answer
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