Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01963481 · ClinicalTrials.gov registry record · Phase 2
Exemestane and Cyclophosphamide for Metastatic Breast Cancer
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01963481: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT01963481 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01963481, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.
Primary Outcome
PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study. The percent of participants with PFS at 3 months will be reported.
Interventions
- DRUG Cyclophosphamide
- DRUG Exemestane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-10-01 |
| Phase | Phase 2 |
What the finished NCT01963481 record still lists
NCT01963481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01963481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01963481 about?
NCT01963481 is a clinical study titled "Exemestane and Cyclophosphamide for Metastatic Breast Cancer". This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.
What is the current status of trial NCT01963481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2013-09. Estimated completion is 2017-10-01.
What interventions are being tested in trial NCT01963481?
The interventions under investigation include: Cyclophosphamide (DRUG), Exemestane (DRUG).
Who is sponsoring clinical trial NCT01963481?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01963481's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia