Clinical trial · Interventional
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate whether hCG will result in a decrease in breast density. High breast density has been associated with an increased risk in breast cancer. It has also been shown that decreasing density with a drug called tamoxifen has resulted in a decreased risk in breast cancer. The investigators are looking at the effect of hCG on breast density in people who are at increased risk of developing breast cancer and our theory postulates that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in breast density in patients who are treated with hCG and tamoxifen versus patients treated with tamoxifen alone. Using this data the investigators will be able to hypothesize that the treatment of hCG will result in a reduction in breast cancer rates in the population and thus make available another drug which can be used to decrease the rates of breast cancer in the population
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hCG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hCG
- description
- Patients at high risk for breast cancer will be treated with hCG
- interventionNames
- Drug: hCG
- type
- NO_INTERVENTION
- label
- routine care
- description
- Patients receiving routine care will be followed
- interventionNames
- Drug: hCG
Primary outcomes (1)
- measure
- The investigators will be looking at the mammographic breast density at the start of the trial and then every 6 months for 2 years. The treatment arm will have 30 injections of Hcg over a 60 day period.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * On tamoxifen therapy for the treatment or prevention of breast cancer. * Must have at least one remaining breast. Exclusion Criteria: * Pregnant or nursing. * No history of allergic reactions to hCG. * Patients who have had bilateral mastectomies. * Uncontrolled thyroid disease. * Cognitively impaired and unable to consent for the trial.
References
Publications (0)
Data not yet available