A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Triple Negative Breast Cancer
- Conditions
- Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)MedDRA version: 19.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10006198 Term: Breast cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004989-23-GB
- Lead Sponsor
- GTx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
Adult women with advanced TNBC with centrally confirmed AR+.
Subject Inclusion Criteria: Subjects eligible for inclusion in this study
must meet all of the following criteria:
1. Able and willing to give voluntary, written and signed, informed consent;
2. Women = 18 years of age;
3. Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for the treatment of advanced or metastatic TNBC;
4. Confirmation of AR+ (defined as = 10% nuclear AR staining by immunohistochemistry [IHC]) TNBC in either the primary or metastatic lesion, assessed prior to the start of or during the screening period by a local laboratory or by medical history;
5. TNBC confirmed by medical history as: human epidermal growth factor receptor 2 [HER2]-negative (confirmed by IHC 0, 1+ regardless of
fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present); estrogen receptor (ER) negative (confirmed as ER expression less than or equal to 1% positive tumor nuclei);
progesterone receptor negative (confirmed as progesterone receptor expression less than or equal to 1% positive tumor nuclei);
6. Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue or new biopsy, if archived tissue is unavailable, for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible;
7. Subjects must have either measurable disease or bone only nonmeasurable disease according to RECIST 1.1;
8. Subjects with bone metastases should be treated with intravenous
bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For subjects who are normocalcemic, therapy can be initiated at the time the subject initiates study drug;
9. Eastern Cooperative Oncology Group (ECOG) performance status 3 0 or 1 at the time of screening and enrollment;
10. Negative serum pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment;
11. For women of childbearing potential who are sexually active, agreement to use a highly effective, non hormonal form of contraception during and for at least 6 months after completion of study treatment;
OR, a fertile male partner willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months after completion of study treatment;
12. Adequate organ function as shown by:
? Absolute neutrophil count = 1,500 cells/mm3
? Platelet count = 100,000 cells/mm3
? Hemoglobin = 9 g/dL
? Serum aspartate aminotransferase (AST) and alani
Subjects eligible for this study must not meet any of the following criteria:
1.Life expectancy < 4 months;
2.Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI) that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]). Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well controlled prior to screening (as assessed by the Investigator) after receiving local therapy (irradiation, surgery, etc.);
3.Radiotherapy within 14 days prior to first dose of study treatment;
4.Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical, or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol;
5.Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening;
6.Positive human immunodeficiency virus (HIV) infection at screening;
7.Prior treatment with any anti-androgens, including but not limited to, enzalutamide and bicalutamide;
8.Major surgery within 28 days of the first dose of study treatment;
9.Be currently taking or have previously taken testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or anti androgens;
10.Treatment with any of the following hormone replacement therapies, unless discontinued at least 28 days prior to the first dose of study treatment:
?Estrogens
?Megesterol acetate;
11.Treatment with any investigational agent within 28 days before the first dose of study treatment;
12.Another active cancer (excluding adequately treated basal cell
carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years;
13.Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
?Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
?Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
?Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome);
14. Current treatment with intra
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method