Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07016399

Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Led by Vandana Abramson · Updated on 2025-10-30

51

Participants Needed

1

Research Sites

420 weeks

Total Duration

On this page

Sponsors

V

Vandana Abramson

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial compares the effect of adding darolutamide to standard therapy versus standard therapy alone before surgery for the treatment of patients with stage II-IIIA androgen receptor positive triple-negative breast carcinoma. Standard therapy before surgery for triple-negative breast cancer typically consists of a combination of chemotherapy and immunotherapy drugs. Chemotherapy drugs, such as carboplatin, paclitaxel, doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide in combination with standard therapy before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

CONDITIONS

Official Title

Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent and willingness to participate
  • Male or female aged 18 years or older
  • ECOG performance status of 0 or 1
  • Newly diagnosed breast cancer with less than 10% estrogen and progesterone receptor staining
  • HER2 negative breast cancer
  • Androgen receptor positive breast cancer with at least 80% AR staining
  • Primary tumor size of 1 cm or larger or stage II-IIIA breast cancer eligible for neoadjuvant therapy
  • Absolute neutrophil count at least 1500/µL within 28 days before treatment
  • Platelet count at least 100,000/µL within 28 days before treatment
  • Hemoglobin level at least 9.0 g/dL within 28 days before treatment
  • Estimated glomerular filtration rate (eGFR) of 60 mL/min or higher within 28 days before treatment
  • Total bilirubin no more than 1.5 times the upper limit of normal (ULN) or direct bilirubin within normal limits if total bilirubin is higher
  • AST and ALT enzymes no more than 2.5 times the ULN within 28 days before treatment
  • Calcium level no higher than 11.5 mg/dL or 2.9 mmol/L within 28 days before treatment
  • Women must not be breastfeeding and agree not to breastfeed during treatment and for at least 120 days after
  • Women of childbearing potential must have a negative pregnancy test within 21 days before treatment and agree to use contraception during and for 120 days after treatment
  • Men must agree to avoid sperm donation for 120 days after treatment
  • Men who can father children must agree to use contraception during and for 120 days after treatment
Not Eligible

You will not qualify if you...

  • Breast cancer that cannot be surgically removed or evidence of metastatic disease
  • Other malignancies within 5 years except low-risk cancers treated with curative intent
  • Pregnancy or breastfeeding
  • Moderate or worse liver impairment (Child-Pugh Class B or higher)
  • Participation in another investigational study within 4 weeks before treatment start, except those in follow-up phase beyond 4 weeks
  • Previous allogeneic tissue or organ transplant
  • Known severe allergic reactions to study drugs or their components
  • History of myocarditis, pericarditis, or significant heart disease
  • Stroke or transient ischemic attack within 6 months before treatment
  • Uncontrolled illness such as active infection or psychiatric/social issues limiting compliance
  • Conditions preventing the use of checkpoint inhibitors such as pembrolizumab

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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