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Aromatase Inhibitor

AZD9833 + Palbociclib for Breast Cancer (SERENA-4 Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease
Have breast cancer that cannot be treated with surgery or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 weeks post progression (up to approximately 5 years)
Awards & highlights

SERENA-4 Trial Summary

This trial is testing whether a new drug combo is better than a current standard of care for treating a certain type of breast cancer.

Who is the study for?
This trial is for adults with ER-positive, HER2-negative advanced breast cancer who haven't had systemic treatment for their condition. Eligible participants include pre-/peri-menopausal women or men willing to take LHRH agonists and those with measurable disease or certain bone lesions. Exclusions apply to those with specific health issues, past treatments that failed within a year, or uncontrolled brain metastases.Check my eligibility
What is being tested?
The study tests the effectiveness of AZD9833 combined with palbociclib against anastrozole plus palbociclib in treating advanced breast cancer. It aims to determine if the new combination is superior as an initial treatment option for patients who have not received prior systemic therapy.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk, liver function changes, and possible allergic reactions. Side effects can vary based on individual health conditions and responses to the medication.

SERENA-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't received any systemic anti-cancer treatments for my ER+ recurrent or metastatic cancer.
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My breast cancer cannot be treated with surgery or radiation.
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My cancer can be measured by scans or I have a bone lesion that can be seen on CT or MRI.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have never had systemic therapy for advanced breast cancer.
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My breast cancer is ER+ and HER2-negative, confirmed by lab tests.
Select...
My tumor is ER positive but does not have high levels of HER2.
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My breast cancer has spread or returned after 2 years of hormone therapy.

SERENA-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 weeks post progression (up to approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 weeks post progression (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
Secondary outcome measures
Change from baseline in EORTC QLQ-BR45 scale scores
Change from baseline in EORTC QLQ-C30 scale scores
Clinical benefit rate at 24 weeks (CBR24)
+8 more

SERENA-4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AZD9833 + palbociclibExperimental Treatment4 Interventions
The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily)
Group II: Anastrozole + palbociclibActive Control4 Interventions
The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
AZD9833
2021
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,603,912 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04711252 — Phase 3
Breast Cancer Research Study Groups: AZD9833 + palbociclib, Anastrozole + palbociclib
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT04711252 — Phase 3
Anastrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711252 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it presently possible to sign-up for this clinical trial?

"This trial is currently looking for participants. It was originally posted on January 28, 2021 and was last updated on October 26, 2022."

Answered by AI

What other similar medical studies have there been for AZD9833?

"As of right now, there are 204 different clinical trials being conducted that involve AZD9833. 40 of those trials are in their third and final phase. Even though a large majority of the trials are based in Burgas, New jersey, there are actually 13885 total locations running these tests."

Answered by AI

At how many different locations is this experiment being conducted presently?

"To make participating more convenient for patients, this trial is being conducted at 50 sites. Some of these locations include Pittsburgh, Solvang, and Omaha. However, there are many other locations across the country."

Answered by AI

What are the common indications for AZD9833?

"While typically used to treat patients that have undergone 2-3 years of tamoxifen therapy, AZD9833 can also help patients suffering from hypogonadotropic ovarian failure, invasive early breast cancer, and female infertility."

Answered by AI

Are the age restrictions for this trial flexible?

"This study is open to adults that are 18 years or older and have not yet reached their 130th birthday."

Answered by AI

How many people total will be enrolled in this clinical trial?

"The data available on clinicaltrials.gov indicates that this is an ongoing study that is looking for 1342 patients from 50 different locations. This trial was first posted on 1/28/2021 and was most recently updated on 10/26/2021."

Answered by AI

What is the latest update on the FDA's stance on AZD9833?

"AZD9833 is in Phase 3 clinical trials, so there is some evidence of its efficacy and multiple rounds of data supporting its safety, which our team at Power estimates to be a 3 on a scale from 1 to 3."

Answered by AI

Are there any specific medical qualifications necessary to join this clinical trial?

"This clinical trial is recruiting 1342 participants with breast cancer who are between the ages of 18 and 130. The following are the inclusion criteria for this trial:-The breast cancer cannot be treated with surgery or radiation-The breast cancer has already spread to other parts of the body or has come back after at least 2 years of standard endocrine treatment-The tumors do not overexpress HER2 protein-The participants have never received any cancer therapy that affects the whole body for advanced breast cancer-The participants are able to do their daily activities-The participants are pre-/peri-men"

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
2021. "A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04711252.
All > Breast Cancer Austin
~581 spots leftby Aug 2026
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