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 PgR-positive/AR-positive metastatic breast cancer

• Conditions: pre-treated post-menopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/AR-positive metastatic breast cancer; MedDRA version: 15.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003510-13-IT
• Lead Sponsor: IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-12
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with metastatic breast cancer
2. AR receptor positivity of primary tumor cells or tumor cells of a metastatic site is required
3. primary tumor cells or tumor cells of a metastatic site imust be HER2 negative
4. Patients must have measurable disease
5. In case of ER-positive disease, previous endocrine treatment in adjuvant or metastatic setting is required and patients must be resistant to aromatase inhibitors. In particular DHEA will be administered in combination with the same aromatase inhibitor during which the progression of disease was found
6. 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
7. Women must be in post-menopausal status
8. Life expectancy must be of greater of 12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.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.

2.HER2 positivity of primary tumor cells or tumor cells of a metastatic site

3.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 elegibility criteria for enrollment are satisfied

4.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

5.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

6.Have received supplement of estrogen or progesterone within 4 weeks prioir to study enter

7.Major surgery during the 21 days before before starting of protocol therapy or planned during the study treatment.

8.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);

9.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.

10.Participation in another clinical trial with any investigational agents within 3 weeks prior to study screening.

11.Previous treatment with androgens or DHEA. Previous treatment with AI is required in case of ER+ and/or PgR positive tumors

12.History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHEA or AI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified