Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05095207 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
A Phase 1 study of Breast Cancer and Metastasis, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT05095207: Recruiting Phase 1 study of Breast Cancer and Metastasis, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05095207 is a Phase 1 study of Breast Cancer and Metastasis that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 42 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095207, a Phase 1 study of Breast Cancer and Metastasis, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Primary Outcome
For the Phase 1 portion of the trial Bayesian optimal interval (BOIN) design is being used. a minimum of 3 and a maximum of 12 patients enrolled to determine the dose-limiting toxicity (DLT) and will be the recommended phase II dose (RP2D). • A DLT will be defined as: * Grade 3 or 4 non-hematologic toxicity * Grade 3 neutropenia lasting greater than 21 days * Grade 3 or 4 neutropenia with neutropenic fever * Grade 4 hematologic toxicity events experienced within the first 4 weeks (1 cycle) of
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Bicalutamide
Study Locations (3)
New York
- Mount Sinai Beth Israel - New York
- Mount Sinai - West - New York
- Dubin breast Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT05095207 shows while recruiting
NCT05095207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT05095207 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05095207 about?
NCT05095207 is a clinical study titled "Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer". This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
What is the current status of trial NCT05095207?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-09-20. Estimated completion is 2027-12.
What conditions does trial NCT05095207 study?
This clinical trial studies the following conditions: Breast Cancer, Metastasis.
What interventions are being tested in trial NCT05095207?
The interventions under investigation include: Abemaciclib (DRUG), Bicalutamide (DRUG).
Who is sponsoring clinical trial NCT05095207?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05095207 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT05095207's enrollment target sits among peer trials
42 864th of 1224 higher than 356 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI