Actively Recruiting
Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer
Led by St Vincent's Hospital, Sydney · Updated on 2025-05-15
65
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
CONDITIONS
Official Title
Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written and voluntary informed consent.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Age 18 years or older, male or female.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- At least 4 weeks washout from previous treatment and 2 weeks from radiotherapy.
- Adequate blood and organ function within 14 days before first treatment.
- Life expectancy of at least 3 months.
- Women of childbearing potential must agree to abstinence or effective contraception during treatment and for at least 28 days after last seviteronel dose or 6 months after last chemotherapy dose.
- Part 1: Diagnosis of breast cancer including hormone receptor positive, HER2 positive, or triple-negative subtypes.
- Part 2: Diagnosis of triple-negative breast cancer with HER2-negative and less than 1% estrogen/progesterone receptor expression, and androgen receptor positivity.
- At least one measurable lesion by RECIST v1.1.
- Advanced or recurrent breast cancer appropriate for docetaxel treatment.
You will not qualify if you...
- Inability to comply with study and follow-up procedures.
- History of malabsorption or inability/unwillingness to swallow pills.
- Active infection requiring antibiotics.
- Other invasive cancer within 2 years except low recurrence risk cancers.
- Known active tuberculosis.
- Pregnant or breastfeeding women.
- Patients unwilling to use effective birth control from screening to 90 days post treatment.
- Women of childbearing potential without negative pregnancy test before treatment.
- Uncontrolled illness or psychiatric/social conditions limiting compliance or increasing risk.
- History or current HIV infection.
- Significant liver disease (Child-Pugh Class B or C), active viral hepatitis, current drug/alcohol abuse, or cirrhosis.
- Major surgery, open biopsy, or trauma within 28 days before treatment start.
- Symptomatic central nervous system metastasis or carcinomatous meningitis unless stable and off corticosteroids/anticonvulsants.
- Unresolved significant toxicity from prior therapy except alopecia or stable endocrinopathy.
- Recent palliative radiation within 14 days unless recovered from effects.
- Uncontrolled pleural, pericardial effusion, or ascites.
- Known allergy or contraindication to study drugs.
- Use of investigational treatment within 30 days or 5 half-lives before study treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
Research Team
R
Rachel F Dear, PhD
CONTACT
C
Christine Chaffer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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