A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)

Translational Research in Oncology (TRIO)0 sites36 target enrollmentJanuary 3, 2017

Overview

No summary available.

Registry

who.int

Start Date

January 3, 2017

End Date

March 13, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Translational Research in Oncology (TRIO)

•1\. Signed and dated PICF obtained prior to initiation of any study\-specific procedure and treatment.
•2\. Female \= 18 years old.
•3\. Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which NAST is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.
•4\. Known ER, PgR and HER2 statuses.
•5\. Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: subjects with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):
•T1 with T \=1\.0 cm, T2 or T3 by at least one radiographic or clinical measurement
•Either clinically positive (N1 only) or clinically negative axillary nodes (N0\)
•6\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\.
•7\. Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:
•Hematology: Haemoglobin \= 9\.0 g/dl; ANC \= 1\.5 × 109/L; Platelet count \= 100 × 109/L

•1\. Any T0, Tis, T1 \< 1\.0 cm, T4; or N2\-3; or M1 BC.
•2\. Bilateral invasive BC.
•3\. Patient that underwent excisional biopsy of the primary tumor.
•4\. Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and/or refusal of patient to undergo corresponding biopsy in case NAST is planned.
•5\. Prior or concurrent systemic anticancer therapy for BC (immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).
•6\. Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.
•7\. Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).
•8\. Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.
•9\. Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.
•10\. Use of other investigational drug within 28 days of enrollment.