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NCT07016399 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
A Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, sponsored by Vandana Abramson.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT07016399: Recruiting Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, sponsored by Vandana Abramson.
NCT07016399 is a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8 that is actively recruiting participants, run by Vandana Abramson. The registered enrollment target is 51 participants, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07016399, a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Vandana Abramson.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Darolutamide
- PROCEDURE Breast Biopsy Procedure
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2025-09-09 |
| Est. Completion | 2033-10 |
| Phase | Phase 2 |
What NCT07016399 shows while recruiting
NCT07016399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07016399 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07016399 about?
NCT07016399 is a clinical study titled "Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC". 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 can...
What is the current status of trial NCT07016399?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2025-09-09. Estimated completion is 2033-10.
What conditions does trial NCT07016399 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT07016399?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Darolutamide (DRUG), Breast Biopsy Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT07016399?
This trial is sponsored by Vandana Abramson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07016399 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07016399's enrollment target sits among peer trials
51 47th of 73 higher than 27 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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