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New treatment option for Breast Atypical Ductal Hyperplasia
Official title Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
ClinicalTrials.gov ID: NCT06184750
What this study is testing
What is Tamoxifen?
Tamoxifen is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast atypical ductal hyperplasia.
Also referred to as TMX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- 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...
- Women with any of the following:
You likely can't join if
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.