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Selective Estrogen Receptor Modulator
Acolbifene vs. Tamoxifen for Breast Cancer Prevention
Phase 2
Waitlist Available
Led By Carol J Fabian
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 35 years
Eastern Cooperative Oncology Group (ECOG) current performance status ≤2 as documented within 3 months prior to randomization (Karnofsky score >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights
Study Summary
This trial compares two drugs (acolbifene & tamoxifen) to help prevent breast cancer in high-risk women. Results may help measure their effects on markers of breast cancer risk.
Who is the study for?
This trial is for premenopausal women aged 35 or older at high risk for breast cancer, with regular menstrual cycles or using certain contraceptives. Participants must have normal liver function tests, not be considering pregnancy for a year, and willing to use birth control. Exclusions include breastfeeding mothers, those with diabetes on medication, chronic liver disease history, prior invasive cancers within 5 years (except non-melanoma skin), current anticoagulant or hormonal treatments users.Check my eligibility
What is being tested?
The study compares acolbifene against low dose tamoxifen in preventing breast cancer. It involves yearly mammograms plus MRI or ultrasound and may include preventive mastectomy consideration. The trial aims to measure the effects of both drugs on breast tissue markers and blood samples related to cancer risk.See study design
What are the potential side effects?
Potential side effects of acolbifene and tamoxifen can include hot flashes, vaginal dryness or discharge, mood swings, changes in menstruation patterns, leg cramps, headache and an increased risk of blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
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My current health allows me to do daily activities with little or no help.
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I am on long-term antiviral treatment for herpes simplex virus.
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My hepatitis B virus load is undetectable with treatment.
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I had hepatitis C but am cured, or if currently treated, my viral load is undetectable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the relative abundance of the specific sequence of messenger ribonucleic acid (mRNA) that codes for AGR2
Secondary outcome measures
Change in Estrogen Response Gene Index (ERGI)
Change in Hot Flash Score
Change in Menopause-Specific Quality of Life (MENQOL)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (acolbifene)Experimental Treatment3 Interventions
Patients receive acolbifene PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D mammography and collection of blood samples during screening and at the end of acolbifene treatment. In addition, patients undergo RPFNA during screening and during day 1-10 of their menstrual cycle, or if not menstruating, at the convenience of the patient and study staff.
Group II: Group 2 (tamoxifen)Active Control4 Interventions
Patients receive tamoxifen PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D mammography and collection of blood samples during screening and at the end of tamoxifen treatment. In addition, patients undergo RPFNA during screening and day 1-10 of their menstrual cycle, or if not menstruating, at the convenience of the patient and study staff.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,361 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Carol J FabianPrincipal InvestigatorUniversity of Kansas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being treated for diabetes with prescription medication.I am currently taking prescription drugs that suppress my immune system.I am 35 years old or older.I am considered to be before menopause.I agree to use birth control during and 8 weeks before and after the study due to risks from tamoxifen.I am currently taking prescription blood thinners like Coumadin, Xarelto, or Eliquis.I have not changed my progestin IUD status 8 weeks before or after the test.I haven't used progesterone/progestin birth control in the last 8 weeks.I am allergic to tamoxifen, acolbifene, or similar drugs.Your kidney function, as measured by a blood test, is within a certain range.I can stop taking aspirin or aspirin products three weeks before each test.I have a history of chronic liver disease, such as NASH or hepatitis C.I have been treated with tamoxifen for over 2 months.I have been treated with acolbifene for over 2 months.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your bilirubin levels should be within a certain range, as measured within the last 180 days before starting the trial.My current health allows me to do daily activities with little or no help.Your liver enzyme levels are not more than 1.5 times the normal limit.I am willing and able to follow the study's schedule and procedures.I am on long-term antiviral treatment for herpes simplex virus.I am not currently breastfeeding nor have I breastfed in the last 12 months.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus load is undetectable with treatment.Women who have regular periods, unless they are using a specific type of birth control or have had a hysterectomy but still have ovaries.I am at high risk for breast cancer based on certain conditions or a risk model.I had hepatitis C but am cured, or if currently treated, my viral load is undetectable.I have implants in both breasts.I haven't had a cancer more serious than T1 stage, except for non-melanoma skin cancer, in the last 5 years.I am currently pregnant.I had breast cancer within the last 5 years.I have a genetic mutation in BRCA1/2 or PALB2.I have had a deep vein thrombosis, pulmonary embolus, or stroke before.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (acolbifene)
- Group 2: Group 2 (tamoxifen)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open to individuals for this clinical trial?
"At present, this medical trial's recruitment is closed. Initially posted on December 25th 2023 and last updated July 11th 2023, patients are not presently being searched for. Nevertheless, there are over 4,800 other clinical trials currently seeking volunteers to take part in their research efforts."
Answered by AI
Has acolbifene received regulatory acceptance from the FDA?
"The safety of Group 1 (acolbifene) was evaluated to be a 2, as this is still an experimental stage. Despite some data supporting its security, there is currently no evidence that it can achieve its desired effects."
Answered by AI
How many geographical sites are offering access to this exploration?
"Northwestern University in Chicago, Illinois, University of Kansas Cancer Center in Kansas City,Kansas and Ohio State University Comprehensive Cancer Centre in Columbus,Ohio are a few sites that are currently recruiting patients for this trial. Additionally there is 4 other medical centres hosting the study as well."
Answered by AI
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