Is NCT06184750 recruiting in Chicago, IL?

Yes, NCT06184750 is currently recruiting participants at its Chicago, IL location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Chicago, IL

About This Breast Cancer Study in Chicago

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Premenopausal women at the time of enrollment defined by any of the following:

Age under 50 years and regular menstruation (most recent period within the past 3 months)

Age under 50 years and continuous hormonal contraception use and at least one intact ovary

Women who are not postmenopausal based on serum hormone levels. Women with estradiol \> 30 pg/mL and follicle-stimulating hormone (FSH) \< 30 IU/mL are eligible

Women with any of the following:

A history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS) with local therapy completed (as determined by treating physician recommendation and patient acceptance) at least 1 month prior to study entry. (The untreated breast will be the study breast, for both imaging and optional biopsy)

Recent or prior lobular carcinoma in situ (LCIS), or any form of epithelial atypia, flat epithelial (FEA), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH)

Are risk eligible for preventive medication based on a five-year risk of 1.7% or greater, estimated with a validated model: the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool, Tyrer-Cusick, Breast Cancer Surveillance Consortium. If the Tyrer-Cuzick model is used a ten-year risk of 3.4% or greater is acceptable

Are tamoxifen-eligible by American Society of Clinical Oncology (ASCO) guidelines (\>= 2-fold increased risk compared to peer if age \>= 45 years, and \>= 4-fold increased risk if age \< 45 years)

A history of mantle radiotherapy

A moderate penetrance germline pathogenic variant

Participants ≥ 18 and ≤ 55 years old will be enrolled. Our trial objectives are not relevant to females under 18 years of age since breast cancer is extraordinarily rare in this age group, and there are no guidelines regarding use of tamoxifen in children, even if know to be at very high risk for breast cancer when older. Because no dosing or adverse event (AE) data are currently available on the use of tamoxifen in participants \< 18 years of age

Human immunodeficiency virus (HIV)-infected patients are eligible to participate if they are on effective anti-retroviral therapy with undetectable viral load within the prior 6 months

Women with evidence of chronic hepatitis B virus (HBV) infection, are also eligible if the HBV viral load is undetectable; they may be on suppressive therapy, if indicated

Women with a history of hepatitis C virus (HCV) infection are eligible if treated and cured. For those who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Women with herpes simplex virus (HSV) infection are eligible if on chronic or as needed (due to a flare) suppressive antiviral therapy

Hormonal contraceptive users are eligible and should maintain the same hormonal contraceptive preparation throughout the duration of the trial. Changing hormonal contraception after enrollment for medical reasons is allowed

The effects of tamoxifen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because tamoxifen is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; partner vasectomy) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Ability to understand and the willingness to sign a written informed consent document

Breast Imaging Reporting and Data System (BIRADS) 1 or 2. Women with BIRADS 3 findings that have been biopsied and shown to be benign or are stable at 6-months follow-up are allowed

Women who are factor V leiden carriers and have not had a blood clot are eligible, if approved by their treating physician

Exclusion Criteria

BIRADS breast density category A

History of selective estrogen receptor modulator (SERM) use within the past 5 years unless:

Use was less than 6 months duration in the past 5 years and not used in the 1 year prior to enrollment OR

Use was no greater than 2 months duration in the past 1 year and not used in the 6 months prior to enrollment

History of invasive breast cancer

Prior bilateral mastectomy or breast augmentation surgery including breast implants. Prior bilateral excisional surgical biopsy, mastopexy (breast lift) or mammoplasty (breast reduction) is allowed, as long as \> 1 year has passed since the procedure

Women with "mosaic mammographic screening views", i.e., whose larger breast size precludes being imaged within a single mammographic screening view

Current use of a strong CYP3A4 inducer or a strong CYP2D6 inhibitor unless willing and able to discontinue use at least 30 days prior to screening and switch to an alternative medication for the duration of participation, under the advice of their physician. If the physician believes the current medication cannot be replaced, the participant will not be eligible

Current use of Warfarin

Planning to become pregnant within the next two years. Potential study participants will be questioned about this and excluded if they are planning pregnancy over the next 20 months

History of thromboembolism, pulmonary embolism, thrombotic stroke, arterial thrombosis of the extremity or deep vein thrombosis. A history of superficial thrombophlebitis is allowed

History of uterine cancer or atypical uterine hyperplasia with uterus intact

Participants may not be receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen

Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women are excluded from this study because tamoxifen a category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tamoxifen. Breastfeeding should be discontinued if the mother is treated with tamoxifen

Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53

Current use of sex hormones (estrogen, progesterone, or androgens), unless part of hormonal contraception pills

Prior invasive cancer ≥ T1 (other than non-melanoma skin cancer), unless curatively treated, and all treatment was completed \> 5 years prior to enrollment

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT06184750) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Chicago, IL

If you're searching for breast cancer treatment options in Chicago, IL, this clinical trial (NCT06184750) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Chicago, IL

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