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Research Report

Published: Aug 28, 2025

Camizestrant (AZD9833): A Comprehensive Clinical and Strategic Analysis of a Next-Generation Oral SERD in HR-Positive Breast Cancer

Executive Summary

Camizestrant (AZD9833) is an investigational, orally bioavailable, next-generation small molecule drug developed by AstraZeneca, positioned to significantly alter the treatment landscape for hormone receptor-positive (HR+) breast cancer.[1] It belongs to the class of Selective Estrogen Receptor Degraders (SERDs), which function through a dual mechanism: as a complete antagonist of the estrogen receptor (ER), it blocks ER-mediated signaling, and as a degrader, it induces a conformational change that targets the receptor for proteasomal destruction.[1] This comprehensive action is designed to provide a more durable and profound inhibition of the estrogen signaling pathways that drive the majority of breast cancers.

The clinical development of camizestrant has been defined by the robust SERENA program. The Phase II SERENA-2 trial established its superiority over the first-generation SERD, fulvestrant, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with pre-treated ER+/HER2- advanced breast cancer.[4] This benefit was particularly pronounced in the subgroup of patients whose tumors harbored activating mutations in the estrogen receptor 1 gene (

ESR1), a key mechanism of acquired resistance to standard endocrine therapies.[4]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants	2024/08/09	NCT06547164	Phase 1	Completed	AstraZeneca
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer	2024/04/24	NCT06380751	Phase 3	Recruiting	AstraZeneca
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors	2024/01/03	NCT06188520	Phase 1	Recruiting	AstraZeneca
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)	2023/07/19	NCT05952557	Phase 3	Recruiting	AstraZeneca
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects	2023/03/30	NCT05790304	Phase 1	Completed	AstraZeneca
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy	2023/03/20	NCT05774951	Phase 3	Recruiting	AstraZeneca
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole	2022/09/23	NCT05551897	Phase 1	Completed	AstraZeneca
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers	2022/06/29	NCT05438303	Phase 1	Completed	AstraZeneca
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)	2021/07/16	NCT04964934	Phase 3	Active, not recruiting	AstraZeneca
AZD9833 China PK Study	2021/03/26	NCT04818632	Phase 1	Completed	AstraZeneca

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations

4 months ago

AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.

AstraZeneca Exits Neuroscience Research to Focus on Core Therapeutic Areas

5 months ago

• AstraZeneca has officially closed its neuroscience research group, discontinuing programs for Alzheimer's disease, migraine, and pain conditions to redirect resources toward higher-value projects. • The strategic shift allows the pharmaceutical giant to concentrate on its core therapeutic areas including oncology, cardiovascular, respiratory diseases, weight management, and immunology. • Despite recording 10% revenue growth in Q1 2025 with nearly $13.6 billion in sales, AstraZeneca executives emphasized they "cannot be everywhere," stating CNS research is "better managed by other companies."

AstraZeneca's Camizestrant Shows 56% Reduction in Breast Cancer Progression Risk Using Blood Test-Guided Treatment

6 months ago

AstraZeneca's experimental drug camizestrant reduced the risk of disease progression or death by 56% in patients with hormone receptor-positive, HER2-negative breast cancer when guided by liquid biopsy testing.

Sanofi Halts Amcenestrant Development After Disappointing First-Line Breast Cancer Trial

8 months ago

• Sanofi discontinues the development of amcenestrant, an oral selective estrogen receptor degrader (SERD), after it failed in the AMEERA-5 phase 3 trial. • The AMEERA-5 trial compared amcenestrant plus palbociclib to letrozole plus palbociclib as a first-line treatment for HR-positive/HER2-negative advanced breast cancer. • This failure raises concerns about the potential of SERDs in the first-line treatment of breast cancer, impacting other developers in the field. • Sanofi will discontinue all amcenestrant studies, including the AMEERA-6 trial in early-stage HR+ breast cancer patients.

Two Phase III Trials Target Advanced Breast Cancer with Novel Therapeutic Approaches

9 months ago

Two Phase III clinical trials are investigating advanced treatment strategies for hormone receptor-positive, HER2-negative breast cancer in postmenopausal women.

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