Metastatic BreastcancerPhase 2ARTTNCT02000375
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 2 study testing DHEA in people with Metastatic Breastcancer and Estrogen Receptor Positive Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breastcancer, Estrogen Receptor Positive Breast Cancer, Estrogen Receptor Negative Neoplasm
- What is being tested?
- DHEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesItaly
- Study dates
- Mar 2013to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological-documented diagnosis of invasive breast cancer.
- Clinical diagnosis of metastatic breast cancer.
- AR receptor positivity of primary tumor cells or tumor cells of a metastatic site is required. It is strongly recommended that 4 unstained and freshly cut 3-4 μ slides from the primary tumor (or metastatic if the primary is not available) be submitted for IRCCS IRST Laboratorio di Bioscienze for confirmation of AR eligibility; however, if that is not possible, a formalin-fixed paraffin-embedded (FFPE) tissue block will be submitted .
- Tumors with ≥10% positively nuclear-stained cells by immunohistochemistry (IHC) are considered positive for AR.
- Primary tumor cells or tumor cells of a metastatic site can be ER-positive and/or PgRpositive or ER-negative/PgR-negative . Hormone receptor positivity is defined as ER and/or PgR greater than 10 fmol/mg by biochemical assay or greater or equal than 10 percent positive cells by immunohistochemistry.
- Primary tumor cells or tumor cells of a metastatic site must be HER2 negative.
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- Measurable disease, defined in accord to RECIST criteria (version 1.1) as
- at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan or MRI (if slice thickness no grater than 5 mm. If slice thicknesses grater than 5 mm the minimum size miserable lesions at baseline should be twice the slice thickness of baseline scans)
- to be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan or MRI (if slice thickness no grater than 5 mm. If slice thicknesses grater than 5 mm the minimum size miserable nodes at baseline).
- In case of ER-pos disease, previous endocrine treatment in adjuvant or metastatic setting is required and patients must be resistant to aromatase inhibitors that means:
- AI in adjuvant setting: patients should have been treated for at least 1 year and have had a recurrence during this treatment or in the first year after finishing adjuvant treatment
- AI in advanced disease: patients must have received the AI lasting at least 6 months, during which patients must have achieved a tumor response or stabilization ,and have had an objective progression during treatment
- No more than 2 previous lines of chemotherapy for ER-pos tumors and not more than 3 lines of chemotherapy for ER-neg tumors are allowed
- Post-menopausal status defined as:
- Patients of any age who have had a bilateral oophorectomy (including radiation castration)
- Patients 56 years old or older. If the patient has any evidence of ovarian function, biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range) is required.
- Patients 55 years old or younger without period in the last 12 month or with biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range).
- At least 18 years of age
- Life expectancy greater of 12 weeks
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- Adequate organ and marrow function as defined below:
- leukocytes >3,000/mL
- absolute neutrophil count >1,500/mL
- platelets >100,000/mL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN
- creatinine within normal institutional limits OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Patients must exhibit capability of swallow tablets
- Patients must exhibit compliance with an oral treatment
- Patients must exhibit geographic proximity that allows regular access to the Institute for clinical and instrumental examinations is required
- Participants must be willing and able to give informed consent for participation in the study.
Who cannot join
- AR-receptor negativity of primary tumor cells or tumor cells of a metastatic site. AR is reported as negative if less than 10% of cells immunostained in a tumor.
- HER2 positivity of primary tumor cells or tumor cells of a metastatic site
- Physician opinion of a too rapid disease progression (like disease widespread in visceral organs like liver or lung in few months) that could suggest the physician a more benefit from chemotherapy treatment even if eligibility criteria for enrollment are satisfied
- Chemotherapy administration within 3 weeks prior to start of protocol therapy or not recovered from adverse events due to agents administered more than 3 weeks earlier
- Brain metastasis not treated or in progression requiring treatment (radiotherapy, surgery or high dose steroidal and antiedemigen treatment) in the 2 weeks prior to start of protocol therapy. Patients with brain metastasis as unique site of metastasis are excluded
- Have received supplement of estrogen or progesterone within 4 weeks prior to study enter
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- Major surgery during the 21 days before before starting of protocol therapy or planned during the study treatment
- Other detectable malignant neoplastic diseases (even a second primitive breast cancer) in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Participation in another clinical trial with any investigational agents within 3 weeks prior to study screening
- Previous treatment with androgens or DHEA. Previous treatment with AI is required in case of ER+ and/or PgR positive tumors
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHEA or AI
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Oncologia Medica PO Cattolica AUSL della Romagna
Cattolica, 47841
Oncologia medica , PO FAENZA, Ausl della Romagna
Faenza, RA, 48121
Oncologia Medica,E.O. Ospedali Galliera
Genova, 16128
Oncologia Medica PO Lugo, AUSL della Romagna
Lugo, RA
Irccs Irst
Meldola, FC, 47014
Oncologia Medica AOU Policlinico di Modena
Modena, 41124
Oncologia medica PO Ravenna AUSL della Romagna
Ravenna, RA, 48121
Oncologia medica PO Rimini AUSL della Romagna
Rimini
About this study
Official title: 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)
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.
Read more
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:
- Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
- 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
- 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.
- CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
- Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline before study treatment and at the moment of discontinuation of treatment.
Read the detailed description
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:
- Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
- 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
- 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.
- CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
- 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.
- Conditions
- Metastatic Breastcancer, Estrogen Receptor Positive Breast Cancer, Estrogen Receptor Negative Neoplasm, Progesterone Receptor Positive Tumor, Progesterone Receptor Negative Neoplasm, Androgen Receptor Gene Overexpression
- Being tested
- DHEA
- Keywords
- metastatic breastcancer, ER/PgR-negative/AR-positive, ER and/or PgR-positive/AR-positive, Androgen Receptor positve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADrug
Also called Dehydroepiandrosterone
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.
| Study group | Role | What they receive |
|---|---|---|
| DHEA | Experimental | 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. Receives: Drug: DHEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (CB)
the proportion of patients with stability, partial response and complete response of the disease after 4 months of therapy.
Measured: 36 months
Secondary outcomes (9)
Time to tumor progression (TTP)
It is defined as the time from randomization until objective tumor progression NOT including death.
Measured: 36 months
Duration of response (DOR)
The time from the date of response documentation to the date of disease progression documentation.
Measured: 36 months
Overall survival (OS)
The time from the date of randomization to date of death from any cause.
Measured: 36 months
Quality of life Quality of life Quality of life Quality of life
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.
Measured: 36 months
Correlation between AR expression and clinical and biological features
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.
Measured: 36 months
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)
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.
Measured: 36 months
Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic sites (when it is possible) and comparison with the same features of the the primary site.
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.
Measured: 36 months
Circulating Tumor Cells (CTCs) analysis [Optionally, only for patients enrolled at IRCCS IRST of Meldola and who signed additional informed consent ]
Analyzing 15-20 ml peripheral blood (PB). The blood collection will be taken before starting treatment at baseline and at the end of treatment.
Measured: 36 months
Safety
Assessed by collecting adverse events (AE) and serious adverse events (SAE) during the course of the study.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Due to slow recruitment and recent new published data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Pietri, MD, Principal investigator, IRST IRCCS, Meldola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000375
- Sponsor's protocol ID
- IRST174.08
- Other IDs
- 2012-003510-13
- Acronym
- ARTT
- Status last verified
- Sep 2016
- First submitted
- 21 Nov 2013
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pietri E, Massa I, Bravaccini S, Ravaioli S, Tumedei MM, Petracci E, Donati C, Schirone A, Piacentini F, Gianni L, Nicolini M, Campadelli E, Gennari A, Saba A, Campi B, Valmorri L, Andreis D, Fabbri F, Amadori D, Rocca A. Phase II Study of Dehydroepiandrosterone in Androgen Receptor-Positive Metastatic Breast Cancer. Oncologist. 2019 Jun;24(6):743-e205. doi: 10.1634/theoncologist.2018-0243. Epub 2018 Dec 27.
PubMed 30591548
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02000375
- Acronym / sponsor ID
- ARTT / IRST174.08
- Conditions
- Metastatic Breastcancer, Estrogen Receptor Positive Breast Cancer, Estrogen Receptor Negative Neoplasm, Progesterone Receptor Positive Tumor, Progesterone Receptor Negative Neoplasm, Androgen Receptor Gene Overexpression
- Keywords
- metastatic breastcancer, ER/PgR-negative/AR-positive, ER and/or PgR-positive/AR-positive, Androgen Receptor positve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment and recent new published data
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
- 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
- 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.
- CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
- Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline before study treatment and at the moment of discontinuation of treatment.
Detailed description
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:
- Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
- 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
- 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.
- CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHEA | Experimental | Drug: DHEADaily 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Histological-documented diagnosis of invasive breast cancer.
- Clinical diagnosis of metastatic breast cancer.
- AR receptor positivity of primary tumor cells or tumor cells of a metastatic site is required. It is strongly recommended that 4 unstained and freshly cut 3-4 μ slides from the primary tumor (or metastatic if the primary is not available) be submitted for IRCCS IRST Laboratorio di Bioscienze for confirmation of AR eligibility; however, if that is not possible, a formalin-fixed paraffin-embedded (FFPE) tissue block will be submitted .
- Tumors with ≥10% positively nuclear-stained cells by immunohistochemistry (IHC) are considered positive for AR.
- Primary tumor cells or tumor cells of a metastatic site can be ER-positive and/or PgRpositive or ER-negative/PgR-negative . Hormone receptor positivity is defined as ER and/or PgR greater than 10 fmol/mg by biochemical assay or greater or equal than 10 percent positive cells by immunohistochemistry.
Key exclusion criteria (12 listed)
- AR-receptor negativity of primary tumor cells or tumor cells of a metastatic site. AR is reported as negative if less than 10% of cells immunostained in a tumor.
- HER2 positivity of primary tumor cells or tumor cells of a metastatic site
- Physician opinion of a too rapid disease progression (like disease widespread in visceral organs like liver or lung in few months) that could suggest the physician a more benefit from chemotherapy treatment even if eligibility criteria for enrollment are satisfied
- Chemotherapy administration within 3 weeks prior to start of protocol therapy or not recovered from adverse events due to agents administered more than 3 weeks earlier
- Brain metastasis not treated or in progression requiring treatment (radiotherapy, surgery or high dose steroidal and antiedemigen treatment) in the 2 weeks prior to start of protocol therapy. Patients with brain metastasis as unique site of metastasis are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEAAlso: DehydroepiandrosteroneDHEA: 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. | Drug | DHEA |
Primary outcome
Clinical benefit rate (CB)
Time frame: 36 months
the proportion of patients with stability, partial response and complete response of the disease after 4 months of therapy.
9 secondary outcomes
Time to tumor progression (TTP)
Time frame: 36 months
Duration of response (DOR)
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Quality of life Quality of life Quality of life Quality of life
Time frame: 36 months
Correlation between AR expression and clinical and biological features
Time frame: 36 months
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)
Time frame: 36 months
Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic sites (when it is possible) and comparison with the same features of the the primary site.
Time frame: 36 months
Circulating Tumor Cells (CTCs) analysis [Optionally, only for patients enrolled at IRCCS IRST of Meldola and who signed additional informed consent ]
Time frame: 36 months
Safety
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Due to slow recruitment and recent new published data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Derived from this study: PubMed 30591548Pietri E, Massa I, Bravaccini S, Ravaioli S, Tumedei MM, Petracci E, Donati C, Schirone A, Piacentini F, Gianni L, Nicolini M, Campadelli E, Gennari A, Saba A, Campi B, Valmorri L, Andreis D, Fabbri F, Amadori D, Rocca A. Phase II Study of Dehydroepiandrosterone in Androgen Receptor-Positive Metastatic Breast Cancer. Oncologist. 2019 Jun;24(6):743-e205. doi: 10.1634/theoncologist.2018-0243. Epub 2018 Dec 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Pietri, MD principal investigator
IRST IRCCS, Meldola
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DHEA in people with Metastatic Breastcancer and Estrogen Receptor Positive Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to slow recruitment and recent new published data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (CB) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016; AzTrials last refreshed its copy on 26 Oct 2026.