Darolutamide with or without standard therapy for Stage II-IIIA, AR+, TNBC
This study is looking at how a drug called darolutamide, given alone or with standard chemotherapy, affects patients with stage II-IIIA androgen receptor positive (AR+) triple-negative breast cancer (TNBC) before surgery. Standard chemotherapy often includes drugs like carboplatin and cyclophosphamide. Researchers want to see if adding darolutamide helps reduce the growth of cancer cells. You might be able to join if you are 18 or older, have newly diagnosed AR+ TNBC, and meet other health requirements. The main goal is to compare changes in a marker called Ki-67, which shows how fast cancer cells are growing. The study plans to enroll 51 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing darolutamide alone or in combination with standard therapy. It plans to enroll 51 participants.
- What's involved
- You would undergo blood sample collection and breast biopsies. You would receive darolutamide by mouth and/or carboplatin and cyclophosphamide intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, mean ΔKi-67 level, is measured at baseline up to 5 years.
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NCT07016399
Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
Recruiting
PHASE2Ages 18+InterventionalTreatmentVandana AbramsonInvestigator-initiated
~51 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBreast Biopsy ProcedureCarboplatinCyclophosphamideDarolutamideDoxorubicin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean ΔKi-67 level
Measured over Baseline up to 5 years
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Vandana G Abramson · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Signed and dated written informed consent as well as the ability to understand and the willingness to sign written consent prior to study registration
Male or female ≥ 18 years of age on the day of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed newly diagnosed breast cancer with the following requirements:
\<10% staining for estrogen receptor (ER) and progesterone receptor (PR) by immunohistochemistry (IHC)
HER2 negative by fluorescence in situ hybridization (FISH)
AR positive: defined as ≥ 80% staining for AR by IHC
Primary tumor clinically or radiographically ≥ 1cm in size or stage II-IIIA and eligible for neoadjuvant treatment
Absolute neutrophil count (ANC) ≥ 1500/µL (≤ 28 days prior to first dose of protocol-indicated treatment)
Platelets ≥ 100,000/µL (≤ 28 days prior to first dose of protocol-indicated treatment)
Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (≤ 28 days prior to first dose of protocol-indicated treatment)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (as calculated by the Cockcroft-Gault Formula or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) (≤ 28 days prior to first dose of protocol-indicated treatment)
Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), or direct bilirubin ≤ ULN for participants with total bilirubin \> 1.5 x ULN (≤ 28 days prior to first dose of protocol-indicated treatment)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 times institutional upper limit of normal (ULN) (≤ 28 days prior to first dose of protocol-indicated treatment)
Calcium ≤ 11.5 mg/dL or ≤ 2.9 mmol/L; in patients with albumin outside the normal range, calcium (corrected for albumin) must be ≤ 11.5 mg/dL or ≤ 2.9 mmol/L (≤ 28 days prior to first dose of protocol-indicated treatment)
Women must not be breastfeeding and further agree to not breastfeed during study treatment and for at least 120 days after completion of treatment
A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 21 days prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until at least 120 days after completion of treatment
Men must refrain from donating sperm for at least 120 days after completion of treatment
A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until at least 120 days after completion of treatment
Exclusion
Non-resectable breast cancer as assessed by the primary treating surgeon or evidence of metastatic disease
Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
Patient is pregnant or breastfeeding
Patients with moderate hepatic impairment (Child-Pugh Class B cirrhosis or higher)
Is currently participating in or within four weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device
Participants who have entered the follow-up phase of an investigational study may participate as long as it has been four weeks after the last dose or last exposure to the previous investigational agent or investigational device
Recipient of previous allogeneic tissue/solid organ transplant
Known severe hypersensitivity (≥ Grade 3) to study drug, pembrolizumab, carboplatin, doxorubicin/epirubicin, paclitaxel, or cyclophosphamide and/or any of the excipients of these drugs
History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association \[NYHA\] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including transient ischemic attack \[TIA\]) within the past six months (24 weeks) prior to starting study treatment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, or psychiatric illness/social situations that would limit compliance with study requirements
Known conditions that would preclude the use of checkpoint inhibitors
What this trial measures
- Mean ΔKi-67 levelBaseline up to 5 years
The two-sample t-test as well as the Wilcoxon Rank-Sum test will be applied to examine the magnitude of ΔKi-67 between the two study arms. The 95% confidence interval (CI) of the mean difference of ΔKi-67 level between two treatment arms will be reported.