RECRUITING

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Conditions

Breast Carcinoma Breast Ductal Carcinoma In Situ Breast Lobular Carcinoma In Situ Estrogen Receptor-Positive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial

Quick Facts

Study Start:2024-09-19

Study Completion:2027-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06184750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 (estradiol =\< 30 pg/mL, follicle-stimulating hormone \[FSH\] \>= 30 IU/mL) * 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 * 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 * 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 * Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%) * 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 oral contraceptive preparation throughout the duration of the trial. For women who have a levonorgestrel-coated intra-uterine device, removal for medical reasons will be 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) 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) breast density category A on most recent mammogram * 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 breast surgery (mastectomy or breast augmentation surgery including breast implants) * 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 and switch to an alternative medication for the duration of participation, under the advice of their physician. If the physician believes the current medication is medically necessary, 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. 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

Inclusion Criteria

Exclusion 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 (estradiol =\< 30 pg/mL, follicle-stimulating hormone \[FSH\] \>= 30 IU/mL)
* 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
* 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
* 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
* Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* 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 oral contraceptive preparation throughout the duration of the trial. For women who have a levonorgestrel-coated intra-uterine device, removal for medical reasons will be 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) 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) breast density category A on most recent mammogram
* 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 breast surgery (mastectomy or breast augmentation surgery including breast implants)
* 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 and switch to an alternative medication for the duration of participation, under the advice of their physician. If the physician believes the current medication is medically necessary, 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. 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

Contacts and Locations

Principal Investigator

Seema A Khan

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, 85719

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois College of Medicine - Chicago

Chicago, Illinois, 60612

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Seema A Khan, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19

Study Completion Date2027-07-30

Study Record Updates

Study Start Date2024-09-19

Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

Breast Carcinoma
Breast Ductal Carcinoma In Situ
Breast Lobular Carcinoma In Situ
Estrogen Receptor-Positive Breast Carcinoma