Camizestrant + Atirmociclib for Breast Cancer
(SERENA-1b Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, camizestrant and atirmociclib (a CDK4/6 inhibitor), to determine their effectiveness in treating advanced breast cancer that is ER-positive (estrogen receptor-positive) and HER2-negative. The trial targets individuals whose cancer has progressed despite previous treatments, particularly those who have already used CDK4/6 inhibitors. It seeks participants diagnosed with advanced breast cancer who have experienced worsening conditions after their last treatment. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are pre-menopausal, you must start GnRH agonist therapy at least 4 weeks before the study and continue it throughout the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of camizestrant and atirmociclib is generally safe for people with advanced breast cancer. Studies have found that patients tolerate this treatment well, with no major safety issues reported. Camizestrant has also been used safely in other studies when combined with drugs like CDK4/6 inhibitors, which help stop cancer cells from growing. While any treatment can have side effects, current data suggests that people have managed well with this combination. For those considering joining a trial, these findings offer a positive view of the treatment's safety.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about camizestrant and atirmociclib for breast cancer because these drugs offer a fresh approach compared to standard treatments like hormone therapies and chemotherapy. Camizestrant is a potent selective estrogen receptor degrader (SERD), which means it not only blocks estrogen receptors but also helps to degrade them, potentially overcoming resistance seen with other hormone therapies. Atirmociclib, on the other hand, is a CDK4/6 inhibitor that works by halting the cell cycle, thereby preventing cancer cells from multiplying. Together, these drugs target cancer in a complementary way, potentially offering a more effective treatment option for patients with certain types of breast cancer.
What evidence suggests that this trial's treatments could be effective for advanced breast cancer?
Research has shown that the combination of camizestrant and atirmociclib, which participants in this trial will receive, may help treat advanced breast cancer. In one study, nearly half of the patients experienced their cancer either stabilizing or shrinking. On average, patients went 7.4 months without their cancer worsening. Another study found that this combination reduced the risk of the disease worsening or causing death by 56% compared to standard treatments. These findings suggest that camizestrant and atirmociclib together could be effective for people with ER-positive, HER2-negative advanced breast cancer.12367
Are You a Good Fit for This Trial?
This trial is for women with advanced ER-positive, HER2-negative breast cancer who have already been treated with a CDK4/6 inhibitor. Participants must be able to take oral medication, have measurable disease, and meet certain health and reproductive criteria. Those with severe illness or prior use of similar drugs cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Atirmociclib Single Dose
Participants receive a single dose of atirmociclib on Day -1
Doublet Intervention
Participants receive a combination of camizestrant and atirmociclib starting from Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atirmociclib
- Camizestrant
Trial Overview
The study tests the safety of combining camizestrant and atirmociclib in women with advanced breast cancer. All participants receive both drugs by mouth. The main goal is to see how well patients tolerate this combination.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
Advanced Breast Cancer: Results from SERENA-1
In this heavily pretreated population, CBR24 was 49.5% and the median progression-free survival was 7.4 months (95% confidence interval, 5.3-9.3) ...
2.
astrazeneca.com
astrazeneca.com/media-centre/press-releases/2026/fda-odac-vote-on-camizestrant-breast-cancer.htmlUpdate on FDA Advisory Committee vote on camizestrant ...
Median PFS was 16.0 months for patients who switched to the camizestrant combination versus 9.2 months for the comparator arm, and nearly one ...
3.
aacrjournals.org
aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-1198/764086/am/Camizestrant-in-combination-with-three-globallyCamizestrant in combination with three globally approved ...
Conclusion: Camizestrant is well-tolerated, with anti-tumor activity in combination with CDK46i. These results support evaluation of camizestrant 75 mg plus ...
Camizestrant reduced the risk of disease progression or ...
Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment.
Study to evaluate the safety and tolerability of camizestrant ...
Study to evaluate the safety and tolerability of camizestrant in combination with atirmociclib in women with advanced breast cancer - SERENA-1b. Study ...
6.
targetedonc.com
targetedonc.com/view/fda-s-odac-votes-against-camizestrant-in-advanced-breast-cancerFDA's ODAC Votes Against Camizestrant in Advanced ...
“The data show that the combination of camizestrant and ribociclib is safe and well tolerated. Camizestrant monotherapy has no clinically ...
April 30, 2026 Meeting of the Oncologic Drugs Advisory ...
Based on the results of SERENA-6, has clinically meaningful benefit for camizestrant been demonstrated for the treatment of patients with HR+/ ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.