Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Breast Cancer, Male

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Methyltestosterone

Tamoxifen

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormones

Hormone Antagonists

After the baseline imaging with FES- and FDHT-PET is completed, tamoxifen 20mg 1dd1 (standard dosage) plus testosterone (Androgel®) will be started. The first 3 patients will receive 25mg testosterone once daily (half the standard starting dosage for male hypogonadism). If this is well tolerated after 3 weeks, the dosage will be increased to 50mg once daily. Out of precaution, the safety profile of the 50mg dosage in the first 3 patients will be evaluated after all 3 patients have received 50mg testosterone for 2 cycli (8 weeks), prior to proceeding to the next 3 patients. Patients will be treated with tamoxifen and testosterone until disease progression or unacceptable toxicity.

AndroGel

Geke A.P. Hospers, MD,PhD

This is a concise single arm, feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. Male patients with metastatic BC (n=6) are eligible for this study after at least 1 line of conventional endocrine therapy.

Testosterone & Tamoxifen Trial

T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients

Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.

AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV)) and/or tumor tissue (assessed by percentage of ER and AR expression).

Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).

Relation between baseline imaging and tumor characteristics to treatment response.

Difference in adverse events between the two testosterone dosages.

University Medical Center Groningen

Symptoms and General Pathology

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hypogonadism

Neoplastic Processes

Gonadal Disorders

Endocrine System Diseases

Anticoagulants

Reproductive Control Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Calcium

Calcium, Dietary

Chelating Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

Androxal

5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.

Placebo

Andre van As, MD, PhD

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Repros Therapeutics Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testosterone & Tamoxifen Trial	NCT05156606	Male Breast Can...	AndroGel	18 Years -	University Medical Center Groningen
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism	NCT00962637	Secondary Hypog...	Androxal Androxal AndroGel Placebo	18 Years - 68 Years	Repros Therapeutics Inc.
Testosterone & Tamoxifen Trial	NCT05156606	Male Breast Can...	AndroGel	18 Years -	University Medical Center Groningen
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism	NCT00962637	Secondary Hypog...	Androxal Androxal AndroGel Placebo	18 Years - 68 Years	Repros Therapeutics Inc.

Spots Global Cancer Trial Database for androgel

Every month we try and update this database with for androgel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for androgel

Every month we try and update this database with for androgel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for androgel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.