# A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

Source: https://onco.cc/trials/nct04214288/  
OnCo record `nct04214288` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Camizestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.

## Summary

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer is a phase 2 interventional study registered as NCT04214288 by AstraZeneca, with 240 participants enrolled, started 2020-04-22 and due to reach its primary completion in 2022-08-30. Interventions recorded: AZD9833 and Fulvestrant. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: SERENA-2
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04214288
- Phase: 2
- Setting: SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer
- Sponsor: AstraZeneca
- Enrolled: 240
- Outcomes: Progression-free Survival (PFS): AZD9833 75mg 7.2 months vs AZD9833 150mg 7.7 months vs AZD9833 300mg 6.3 months vs Fulvestrant 500 mg 3.7 months; Objective Response Rate (ORR): AZD9833 75mg 15.7% vs AZD9833 150mg 17.1% vs AZD9833 300mg 25.2% vs Fulvestrant 500 mg 11.6%

## Sources

- ClinicalTrials.gov NCT04214288: https://clinicaltrials.gov/study/NCT04214288

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- drugs: [Camizestrant](https://onco.cc/drugs/camizestrant/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- key papers: [Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial](https://onco.cc/key-papers/paper-nct04214288-lancet-oncol-2024/)

---
JSON: https://onco.cc/api/v1/entities/nct04214288.json