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CDK4/6 Inhibitor

AZD9833 + CDK4/6 Inhibitor for Breast Cancer (SERENA-6 Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have advanced breast cancer that is not able to be treated with surgery or radiation

Have an ESR1 mutation in their cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (approximately 3.5 years)

Awards & highlights

SERENA-6 Trial Summary

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

Who is the study for?

This trial is for adults with advanced HR-positive, HER2-negative breast cancer that can't be treated with surgery or radiation. Participants must have been on CDK4/6 inhibitors and aromatase inhibitors for at least 6 months without worsening of their cancer and have a detectable ESR1 mutation. They should be able to perform daily activities and not have severe heart disease, certain CNS metastases, uncontrolled diseases, or previous treatment with AZD9833.Check my eligibility

What is being tested?

The study tests the effectiveness of AZD9833 combined with a CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) against standard treatments using an aromatase inhibitor (anastrozole or letrozole) plus a CDK4/6 inhibitor in patients whose breast cancer has an ESR1 mutation.See study design

What are the potential side effects?

Potential side effects include issues related to organ function such as liver or kidney problems, blood disorders like low white cell counts increasing infection risk, fatigue, nausea, hair loss from chemotherapy drugs involved in the trial regimen.

SERENA-6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced breast cancer cannot be treated with surgery or radiation.

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My cancer has an ESR1 mutation.

Select...

My breast cancer is hormone receptor positive and HER2 negative.

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I have been on CDK4/6 inhibitors and AI for at least 6 months.

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My cancer did not worsen after treatment with an AI and CDK4/6 inhibitor.

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I am 18 years old or older.

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My breast cancer has spread and cannot be removed or cured with surgery or radiation.

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My breast cancer is estrogen receptor positive and HER2 negative.

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I am currently being treated with AI and CDK4/6 inhibitors for advanced disease.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood test shows ESR1 mutation.

SERENA-6 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (approximately 3.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (approximately 3.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (approximately 3.5 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

Neoplasms

Secondary outcome measures

Change from baseline in EORTC QLQ-BR23 scale scores

Change from baseline in EORTC QLQ-C30 scale scores

Chemotherapy free survival

+5 more

SERENA-6 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AZD9833 + palbociclib, abemaciclib or ribociclibExperimental Treatment7 Interventions

The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily)

Group II: Anastrozole or letrozole + palbociclib, abemaciclib or ribociclibActive Control7 Interventions

The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily 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

Ribociclib

2018

Completed Phase 3

~2330

AZD9833

2021

Completed Phase 2

~230

Abemaciclib

2019

Completed Phase 2

~1710

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,613,121 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04964934 — Phase 3

Breast Cancer Research Study Groups: AZD9833 + palbociclib, abemaciclib or ribociclib, Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib

Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04964934 — Phase 3

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964934 — Phase 3

Frequently Asked Questions

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

Could you please go over the potential risks associated with AZD9833?

"There is both efficacy and safety data supporting the use of AZD9833 as it has progressed to a Phase 3 clinical trial."

Answered by AI

Is this study being conducted in multiple locations within the city?

"At the moment, there are 51 clinical trial sites active. These locations include Vancouver, Little Rock, Billings and many others. If you enroll in this study, it is best to choose a clinic near you to limit travel as much as possible."

Answered by AI

What are the intended effects of AZD9833?

"AZD9833 is most commonly used to treat patients that have been on 2-3 years of tamoxifen therapy. Additionally, this medication can be used to help those with hypogonadotropic ovarian failure and early stage breast cancer that has spread beyond the milk ducts."

Answered by AI

If a person is no longer a teenager, can they still participate in this research project?

"This particular study is recruiting adults aged 18 to 130. In total, there are 28 clinical trials underway for patients that are under-aged and 404 separate trials for elderly individuals."

Answered by AI

Which type of person is best suited for this clinical trial?

"This clinical trial is looking for 302 participants who have progressive disease and meet the following additional criteria: adequate organ and marrow function, a proven diagnosis of adenocarcinoma of the breast that cannot be surgically removed or treated with curative intent radiation therapy, documentation of a histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer, currently receiving treatment with an aromatase inhibitor (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or abemaciclib) ± LHRH as initial endocrine based treatment"

Answered by AI

What else is known about AZD9833 from past research?

"AZD9833 was first studied 25 years ago at National Institutes of Health Clinical Center. Since then, there have been a total of 375 completed trials. As of now, 363 clinical trials are actively recruiting patients. A majority of these studies are being conducted in Vancouver, British Columbia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

2021. "Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964934.

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