pharmacological study for Breast Cancer

University of Minnesota, Minneapolis, MN
Breast Cancerpharmacological study - Other
Eligibility
18+
Female
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Study Summary

This trial looks at how well tamoxifen citrate works in reducing breast cancer risk in people who have had radiation therapy.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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SER-155

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 2 years

At year two post treatment
Mammographic Breast Density
Up to 2 years
Biomarker Levels
Biomarker Levels - Alkaline Phosphatase
Biomarker Levels - Urine N-telopeptide
Insulin Growth Factor Levels (IGF1)
Insulin Growth Factor Levels (IGF3 )
Number of Grade 2-4 Toxicities
Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire
Percentage of Pills Taken Out of the Total Prescribed

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
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Side Effects for

Treatment (Enzalutamide)
76%Fatigue
58%Hot flashes
30%Diarrhea
30%Pain
27%Hyperglycemia
24%Back pain
18%Nausea
18%Dizziness
18%Dyspnea
18%Arthralgia
15%Depression
15%Edema limbs
15%Anorexia
15%Headache
15%Pain in extremity
15%Anxiety
15%Hypertension
12%Fall
12%Arthritis
12%Constipation
12%Bone pain
12%Abdominal pain
12%Urinary frequency
12%Cough
9%Generalized muscle weakness
9%Anemia
9%Flank pain
9%Hematuria
9%Pruritis
9%Genital edema
9%Platelet count decreased
9%Urinary incontinence
9%Insomnia
9%Memory impairment
6%Dyspepsia
6%Sinus disorder
6%Confusion
6%Renal and urinary disorders - Other
6%Skin and subcutaneous tissue disorders - Other
6%Peripheral sensory neuropathy
6%Blood bilirubin increased
6%Muscle weakness lower limb
6%Blurred vision
6%Alkaline phosphatase increase
6%Vomiting
6%Renal calculi
3%General disorders and administration site conditions - Other
3%Alopecia
3%Upper respiratory infection
3%Hypokalemia
3%Skin infection
3%Cystitis noninfective
3%Fracture
3%Weight gain
3%Infections and infestations - Other
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT02012296) in the Treatment (Enzalutamide) ARM group. Side effects include: Fatigue with 76%, Hot flashes with 58%, Diarrhea with 30%, Pain with 30%, Hyperglycemia with 27%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Arm I (tamoxifen citrate)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

84 Total Participants · 2 Treatment Groups

Primary Treatment: pharmacological study · Has Placebo Group · Phase 2

Arm I (tamoxifen citrate)Experimental Group · 10 Interventions: Fine needle aspiration, Quality of Life Assessment, immunohistochemistry staining method, protein expression analysis, questionnaire administration, pharmacogenomic studies, Tamoxifen Citrate, Digital mammography, pharmacological study, laboratory biomarker analysis · Intervention Types: Procedure, Other, Other, Genetic, Other, Other, Drug, Procedure, Other, Other
Arm II (placebo)PlaceboComparator Group · 10 Interventions: Fine needle aspiration, Quality of Life Assessment, immunohistochemistry staining method, protein expression analysis, questionnaire administration, pharmacogenomic studies, Placebo, Digital mammography, pharmacological study, laboratory biomarker analysis · Intervention Types: Procedure, Other, Other, Genetic, Other, Other, Drug, Procedure, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fine needle aspiration
2015
N/A
~290
protein expression analysis
2005
Completed Phase 2
~1100
Tamoxifen
FDA approved
Digital mammography
2016
N/A
~29460

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

City of Hope National Medical CenterOTHER
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3,811 Total Patients Enrolled
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2,050 Patients Enrolled for Breast Cancer
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University of Alabama at BirminghamLead Sponsor
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National Cancer Institute (NCI)NIH
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St. Jude Children's Research HospitalOTHER
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Dana-Farber Cancer InstituteOTHER
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M.D. Anderson Cancer CenterOTHER
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Wake Forest UniversityOTHER
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University of MinnesotaOTHER
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University of Colorado, DenverOTHER
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Smita Bhatia, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 18+ · Female Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What locations are offering access to this clinical trial?

"The clinical trial is being conducted at multiple centres, including St. Jude Children's Research Hospital in Memphis, Tennessee, City of Hope Medical Center in Duarte, California and Mayo Clinic in Rochester, Minnesota amongst 13 other prominent sites." - Anonymous Online Contributor

Unverified Answer

Are there any other investigations utilizing pharmacological research techniques?

"Presently, 67 clinical trials exploring pharmacological study are underway. 22 of these studies have proceeded to Phase 3 and can be found in Ann Arbor, Michigan as well as 7276 other locations." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently participating in this research endeavor?

"This clinical experiment is not currently recruiting. It was initially released on the 1st of September in 2010, and its most recent update occurred on April 12th 2022. However, those seeking to participate in other studies may have better luck - there are 2596 medical trials related to breast cancer presently admitting patients as well as 67 drug-based investigations open for enrollment." - Anonymous Online Contributor

Unverified Answer

What safeguards are in place to protect participants during pharmacological research?

"The safety rating of this pharmacological study is 2, as it currently exists in Phase 2. This suggests that there are some studies to support its security but no evidence for efficacy." - Anonymous Online Contributor

Unverified Answer

What kinds of illnesses are studied with pharmaceutical research?

"Pharmacological study is commonly prescribed to combat malignant neoplasms, and has been used in the past to treat ovarian cancer, induce ovulation, or prevent high risk outcomes." - Anonymous Online Contributor

Unverified Answer

Is there an ongoing recruitment process for this investigation?

"At this moment in time, no participants are being accepted for the clinical trial in question. This particular research endeavour was initially posted on September 1st 2010 and most recently updated April 12th 2022. If you're searching other studies, there are 2596 trials related to breast cancer that are actively recruiting patients as well as 67 pharmacological experiments doing the same." - Anonymous Online Contributor

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

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