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Phase 2 Breast Cancer Trial, Recruiting
NCT06184750
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Women who are premenopausal — meaning either under 50 with a period in the last 3 months, under 50 using continuous hormonal contraception with at least one intact ovary, or with hormone blood test results showing estradiol above 30 pg/mL and FSH below 30 IU/mL
- Women aged 18 to 55 years old
- Women who have a personal history of a type of non-invasive breast condition called ductal carcinoma in situ (DCIS) that was estrogen receptor positive, in one breast only, with treatment finished at least 1 month before joining the trial
- Women with a history of lobular carcinoma in situ (LCIS) or certain non-cancerous breast cell changes, including flat epithelial atypia (FEA), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH)
- Women whose estimated 5-year breast cancer risk is 1.7% or higher (or 10-year risk of 3.4% or higher if the Tyrer-Cuzick risk tool is used), as calculated by an approved risk assessment tool
- Women whose breast cancer risk level meets the American Society of Clinical Oncology (ASCO) guidelines for being considered eligible for tamoxifen as a preventive medication (confirm with trial site for the exact risk thresholds that apply to a given age)
- Women who have previously had mantle radiotherapy (a type of radiation treatment to the chest area)
- Women who carry a moderate-risk gene variant linked to breast cancer (confirm with trial site which specific variants qualify)
- Women living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
- Women with a history of chronic hepatitis B virus (HBV) infection, if the virus is currently undetectable in the blood (they may or may not be on suppressive treatment)
- Women with a past hepatitis C virus (HCV) infection who have been treated and cured, or who are currently on treatment with an undetectable viral load
- Women with herpes simplex virus (HSV) who are on ongoing or as-needed antiviral treatment
- Women using hormonal contraception, provided they continue using the same contraception throughout the trial (changes for medical reasons after joining are allowed)
- Women who agree to use effective contraception throughout the trial, as tamoxifen can harm a developing baby — methods accepted include hormonal or barrier contraception, abstinence, or a partner who has had a vasectomy
- Women with a mammogram result classified as BIRADS 1 or 2 (meaning no concerning findings or only routine findings); women with a BIRADS 3 result (something needing follow-up) that has been biopsied and found to be non-cancerous, or has been stable for 6 months, are also eligible
- Women who carry the factor V Leiden genetic variant and have never had a blood clot, if their treating doctor approves their participation
- Women who are able to understand the study and are willing to sign a written consent form
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- Women whose mammogram shows the least dense breast tissue category (BIRADS density category A)
- Women who have used a selective estrogen receptor modulator (SERM) medication (a class that includes tamoxifen and similar drugs) within the past 5 years, unless the use was brief and meets specific timing conditions (confirm with trial site for the exact cut-offs that may apply)
- Women with a history of invasive breast cancer
- Women who have had both breasts removed (bilateral mastectomy) or have had breast implants placed; note that prior breast lift, breast reduction, or surgical biopsy in both breasts is allowed if it was more than 1 year ago
- Women whose breasts are too large to fit within a single standard mammogram image view
- Women currently taking a strong CYP3A4 inducer or strong CYP2D6 inhibitor medication (certain drugs that affect how the body processes tamoxifen), unless their doctor agrees they can switch to an alternative medication at least 30 days before the screening visit and for the entire trial period
- Women currently taking the blood-thinning medication warfarin
- Women who are planning to become pregnant within the next approximately 20 months
- Women with a personal history of blood clots, including deep vein thrombosis, pulmonary embolism, thrombotic stroke, or arterial blood clots in a limb (a history of superficial thrombophlebitis, a milder clotting condition in a surface vein, is allowed)
- Women with a history of uterine cancer or abnormal uterine cell changes (atypical uterine hyperplasia) who still have their uterus
- Women currently taking part in another clinical trial involving an investigational treatment
- Women with a known allergy to tamoxifen or to chemically similar compounds
- Women with uncontrolled serious illness, or mental health or social circumstances that would make it difficult to follow the trial requirements
- Women who are currently pregnant or breastfeeding
- Women known to carry high-risk breast cancer gene mutations, including BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, or TP53
- Women currently using sex hormone medications — such as estrogen, progesterone, or androgens — unless these are part of a hormonal contraceptive pill
- Women with a history of an invasive cancer (other than certain non-melanoma skin cancers) that was stage T1 or higher, unless treatment was completed more than 5 years before joining the trial and the cancer was treated with curative intent
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
27 September 2024
Est. completion
31 March 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Response at any time point
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.