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Breast Diseases

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Androgens

Exemestane

Letrozole

Anastrozole

Dehydroepiandrosterone

Adjuvants, Immunologic

Immunologic Factors

DHEA (Dehydroepiandrosterone)

Daily oral administration of DHEA at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption.

DHEA: Daily oral administration of DHEA(Dehydroepiandrosterone) at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption.

DHEA

Elisabetta Pietri, MD

A phase II non randomized study evaluating the role of Androgen Receptors as Targets for therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/AR-positive metastatic breast cancer.

Study Design: Multicentric, Open-label not randomized trial.

Description of Study Treatment:

Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption until discontinuation for progression of disease, unacceptable toxicity or discontinuation/withdrawal of participants from study treatment.

Number of Subjects:

12 patients per group in the first step; if the number of responders is greater or equal to 2, recruitment will continue up to a total of 35 patients (per group).

For the biological part, we will evaluate:

1. Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or PgR-positive/AR-positive
3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is possible) and comparison with the same features of primitive tumor.
4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline before study treatment and at the moment of discontinuation of treatment.

A phase II non randomized study evaluating the role of Androgen Receptors as Targets for therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/AR-positive metastatic breast cancer.

Study Design: Multicentric, Open-label not randomized trial.

Description of Study Treatment:

Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption until discontinuation for progression of disease, unacceptable toxicity or discontinuation/withdrawal of participants from study treatment.

Number of Subjects:

12 patients per group in the first step; if the number of responders is greater or equal to 2, recruitment will continue up to a total of 35 patients (per group).

For the biological part, we will evaluate:

1. Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or PgR-positive/AR-positive
3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is possible) and comparison with the same features of primitive tumor.
4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline before study treatment and at the moment of discontinuation of treatment.

Statistical Considerations:

The sample size required for each treatment arm will be predicted using a SIMON two-stage design with a 10 percent alpha and beta error.

Assuming an acceptable minimum clinical benefit P0 equal to 10 percent and an auspicious clinical benefit P1 equal to 30 percent, we plan to recruit 12 patients per group in the first step.

If the number of responders is greater or equal to 2, recruitment will continue up to a total of 35 patients (per group).

If the number of responders is greater or equal to 6, the combination will be considered active and worthy of further evaluation.

If a subgroup population is discontinued at the end of the first step, the study will be continued with the other subgroup.

A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)

A Phase II Non Randomized Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)

the proportion of patients with stability, partial response and complete response of the disease after 4 months of therapy.

It is defined as the time from randomization until objective tumor progression NOT including death.

The time from the date of response documentation to the date of disease progression documentation.

The time from the date of randomization to date of death from any cause.

FACT ( Functional Assessment of Cancer Therapy ) -B : a 36-item compilation, subdivided into four primary QOL (Quality of life) domains and a disease specific domain - additional concerns for breast cancer.

Immunohistochemistry for steroid receptors. Antigen expression is evaluated at light microscope (x 200) by two independent observers.

The positivity is expressed as the percentage ratio between immunoreactive and total number of tumor cells. The cut off value \> 10%for AR will be adopted.

Analyzing 15-20 ml peripheral blood (PB). The blood collection will be taken before starting treatment at baseline and at the end of treatment.

Assessed by collecting adverse events (AE) and serious adverse events (SAE) during the course of the study.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Triple Negative Breast Neoplasms

Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

DHEA administration will begin approxiately 14 days prior to surgery.

Surgical procedure of the invasive breast cancer

Surgical resection

Zeina Nahleh, MD

RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an effective treatment for women with breast cancer.

PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

OBJECTIVES:

Primary

* To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor proliferation in women with estrogen receptor-negative, progesterone receptor-negative, HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of the breast.

Secondary

* To study the effect of DHEA on expression of AR in these patients.
* To assess the effect of DHEA on changes in serum estrogen and androgen hormone levels (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) in these patients.
* To assess the toxicity of DHEA in these patients.
* To follow the clinical course of these patients.

OUTLINE: Patients receive oral dehydroepiandrosterone (DHEA) twice daily on days -14 to 0. Patients then undergo surgery on day 1.

Tissue samples are collected at baseline and at the time of surgery for biomarker analysis (androgen receptor, estrogen receptor, progesterone receptor, HER2/neu, Ki-67, and p53) by IHC. Blood samples are collected at baseline and after completion of treatment with DHEA for analysis of serum hormone (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) and cytokine levels.

After completion of study therapy, patients are followed up at 1 week and then every 6 months for 3 years.

DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer

National Cancer Institute (NCI)

Barbara Ann Karmanos Cancer Institute

Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

DHEA : DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection : Surgical procedure of the invasive breast cancer

DHEA, Surgical Resection

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Elaina Gartner

Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery \& refused follow up.

Tumor Proliferation (Percentage of Ki-67 Positive Cells)

Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

DHEA: DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection: Surgical procedure of the invasive breast cancer

Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression

DHEA, surgical resection:

Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

DHEA: Administration will begin approxiately 14 days prior to surgery.

Surgical resection: Surgical procedure of the invasive breast cancer

Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)

Toxicity

Overall Study

Symptoms and General Pathology

Recurrence

Breast Neoplasms, Male

Breast Cancer, Male

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

A daily dose of 2.5 mg will be used throughout the study.

letrozole

Will be dispensed in either 500mg or 1000mg tablets. Subjects will start at a dose of 500 mg and may increase up to 5000mg depending on the cohort.

PK draws will happen on day 1 and day 14, then every 2 weeks.

pharmacological study

Rodney F. Pommier, MD

RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.

OBJECTIVES:

* To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.

OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.

Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer

Subjects will be monitored at day 14 and then every 2 weeks for up to one year.

OHSU Knight Cancer Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Vaginitis

Atrophy

Atrophic Vaginitis

Pathological Conditions, Anatomical

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Daily administration of one placebo vaginal ovule at bedtime

Placebo

Daily administration of one prasterone vaginal ovule at bedtime

Prasterone (DHEA)

Claude Labrie, M.D., Ph.D.

David F Archer, M.D.

Sheryl Kingsberg, Ph.D.

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.

Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)

Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.

Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.

AMAG Pharmaceuticals, Inc.

EndoCeutics Inc.

Sarcoma

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

-DHEA is an oral supplement which will be administered on an outpatient basis at the prescribed dose daily on a 28-day cycle.

* Baseline, Cycle 1 Day 15, and Day 1 of each cycle beginning with Cycle 2
* 7 questions with answers ranging from 0=Not At All to 4 = Very Much.

FACT-67 validated survey

Brian A Van Tine, M.D., Ph.D.

DHEA is a natural allosteric inhibitor of glucose-6-phosphate dehydrogenase (G6PD). G6PD is a key regulatory enzyme for the survival of synovial sarcoma. The investigators postulate that they can inhibit the production of NADPH in synovial sarcoma and cause cell death by using a naturally occurring G6PD inhibitor.

DHEA in Synovial Sarcoma Patients

A Phase I/II Clinical Trial of Dose-Escalating DHEA in Synovial Sarcoma Patients

* MTD is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached.
* Dose-limiting toxicities are defined as one of the following events occurring during the 1st cycle of treatment thought to be possibly, probably, or definitely related to treatment:

  * Grade 3 or greater liver function test abnormalities
  * Grade 3 or greater psychiatric disorder
  * Quality of life (QOL) alteration (change in score of 30%)

* Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction inf short axis to \<10mm, disappearance of all non-target lesions and normalization of tumor marker level.
* Partial response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
* Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diaters while on study

* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
* Progressive disease (PD): aAppearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)	NCT02000375	Metastatic Brea... Estrogen Recept... Estrogen Recept... Progesterone Re... Progesterone Re... Androgen Recept...	DHEA	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer	NCT00972023	Breast Cancer	DHEA Surgical resect...	18 Years - 120 Years	Barbara Ann Karmanos Cancer Institute
A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)	NCT02000375	Metastatic Brea... Estrogen Recept... Estrogen Recept... Progesterone Re... Progesterone Re... Androgen Recept...	DHEA	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer	NCT00516542	Breast Cancer	letrozole DHEA pharmacological...	60 Years -	OHSU Knight Cancer Institute
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer	NCT03740945	Vaginal Atrophy...	Placebo Prasterone (DHE...	30 Years - 80 Years	EndoCeutics Inc.
DHEA in Synovial Sarcoma Patients	NCT02683148	Synovial Sarcom... Sarcoma, Synovi...	DHEA FACT-67 validat...	16 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for dhea

Every month we try and update this database with for dhea 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 dhea

Every month we try and update this database with for dhea 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 dhea 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.