A Presurgical Tissue-Acquisition Study

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

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Morales, Leticia; Pelley, Jennifer; Jobson, Gillian S

  • IRB No: WIRB 20162284

    Protocol Abbrev: TRIO 030

    Principal Investigator: Regan Derek Rostorfer, MD

    Sub Investigators: Cuesta, Ana MD; Baidas, Said MD; Moroose, Rebecca MD; Shah, Nikita MD

    Age Group: Adult

    Treatment: ODM-201

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Surgery

    ClinicalTrials.gov ID: NCT03004534

  • Objective

    To identify the molecular alterations that occur in human BC tissue, following short-term exposure to ODM-201 in female subjects with EBC.

  • Key Eligibility

    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.
    4. Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: subjects with multifocal/multicentric tumors are eligible). Subject must have (according to TNM 7th edition rules):
    T1 with T ≥1.5cm, T2 or T3 by at least one radiographic or clinical measurement
     Either clinically positive (N1 only) or clinically negative axillary nodes (N0)
     M0
    5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
    6. Adequate organ function within 28 days prior to enrollment
    7. No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the time of the first intake of ODM-201.
    8. WoCBP* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of ODM-201.
    9. For WoCBP* negative serum pregnancy test within 7 days of enrollment.
    10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.