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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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

Spots Global Cancer Trial Database for androgen receptor positve