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# Positive Results in AZ Breast Cancer Trials
- URL: https://www.fdaweb.com/positive-results-in-az-breast-cancer-trials/
- Published: 2022-10-26T12:00:00.000Z
- Updated: 2026-09-14T18:04:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153061

AstraZeneca has reported positive high-level results from the SERENA-2 Phase 2 trial and the CAPitello-291 Phase 3 trial of new breast cancer drugs. The company [says](https://www.astrazeneca.com/media-centre/press-releases/2022/camizestrant-significantly-improved-progression-free-survival.html?ref=fdaweb.com) the SERENA-2 trial showed that AZ’s next-generation oral selective estrogen receptor degrader camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival benefit at 75mg and 150mg dose levels versus the company’s Faslodex (fulvestrant) 500mg in post-menopausal patients with estrogen receptor-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy for advanced disease.

AZ says camizestrant was well tolerated and its safety profile was consistent with that observed in previous trials with no new safety signals identified.

For the CAPitello-291 trial, AZ [says](https://www.astrazeneca.com/media-centre/press-releases/2022/capivasertib-phase-iii-trial-met-primary-endpoints.html?ref=fdaweb.com) capivasertib combined with Faslodex demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo plus Faslodex in patients with HR-positive, HER2-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy, with or without a CDK4/6 inhibitor.

The trial met both primary endpoints, the company says, and the capivaserib safety profile was similar to that observed in previous trials evaluating the combination.