Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01602380 · ClinicalTrials.gov registry record · Phase 3
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT01602380: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01602380 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01602380, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study Summary
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
Primary Outcome
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Interventions
- DRUG faslodex 500mg
- DRUG arimidex 1mg
- DRUG faslodex dummy
- DRUG arimidex dummy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2012-10-17 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 3 |
What the finished NCT01602380 record still lists
NCT01602380 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which faslodex 500mg is the first listed.
NCT01602380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01602380 about?
NCT01602380 is a clinical study titled "A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.". The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
What is the current status of trial NCT01602380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2012-10-17. Estimated completion is 2026-01-16.
What interventions are being tested in trial NCT01602380?
The interventions under investigation include: faslodex 500mg (DRUG), arimidex 1mg (DRUG), faslodex dummy (DRUG), arimidex dummy (DRUG).
Who is sponsoring clinical trial NCT01602380?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01602380's enrollment target sits among peer trials
462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT00949819 · 462 participants
Active Surveillance for Cancer of the Prostate (ASCaP)
- NCT05126277 · 462 participants · Phase 3
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
- NCT04546399 · 461 participants · Phase 2
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
- NCT04787744 · 464 participants · Phase 2
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
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