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NCT03616587 · ClinicalTrials.gov registry record · Phase 1
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
A Phase 1 study of ER+ HER2- Advanced Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 396
- Enrollment target
- 17
- Study locations
NCT03616587: Active Phase 1 study of ER+ HER2- Advanced Breast Cancer, sponsored by AstraZeneca.
NCT03616587 is a Phase 1 study of ER+ HER2- Advanced Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 396 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (560% higher). The trial reports 17 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616587, a Phase 1 study of ER+ HER2- Advanced Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 396 participants
- Enrollment target
- 17
- Study locations
Study Summary
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
Primary Outcome
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.
Conditions Studied
Interventions
- DRUG AZD9833
- DRUG AZD9833 with palbociclib
- DRUG AZD9833 with everolimus
Study Locations (17)
Other
- Research Site - Barcelona
- Research Site - Barcelona
- Research Site - Madrid
- Research Site - Madrid
- Research Site - Seville
- Research Site - Valencia
- Research Site - Cambridge
- Research Site - Leeds
- Research Site - London
- Research Site - Manchester
- Research Site - Sutton
- Research Site - Sutton
Colorado
- Research Site - Aurora
Florida
- Research Site - Sarasota
Pennsylvania
- Research Site - Philadelphia
Tennessee
- Research Site - Nashville
Utah
- Research Site - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2027-06-24 |
| Phase | Phase 1 |
What the registry record for NCT03616587 still lists
NCT03616587 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (560% higher).
The record links to 1 condition, with ER+ HER2- Advanced Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which AZD9833 is the first listed.
NCT03616587 lists 17 locations in 6 states (Other, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT03616587 about?
NCT03616587 is a clinical study titled "Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.". A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
What is the current status of trial NCT03616587?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 396 participants. The study started on 2018-10-11. Estimated completion is 2027-06-24.
What conditions does trial NCT03616587 study?
This clinical trial studies the following conditions: ER+ HER2- Advanced Breast Cancer.
What interventions are being tested in trial NCT03616587?
The interventions under investigation include: AZD9833 (DRUG), AZD9833 with palbociclib (DRUG), AZD9833 with everolimus (DRUG).
Who is sponsoring clinical trial NCT03616587?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03616587 being conducted?
This trial has 17 study locations across Colorado, Florida, Pennsylvania, Tennessee, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ER+ HER2- Advanced 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 NCT03616587's enrollment target sits among peer trials
396 77th of 2000 higher than 1,924 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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