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CDK4/6 Inhibitor

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

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

Have an ESR1 mutation in their cancer

Must not have

Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term

Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease

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

Pivotal 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.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to vital organs and poses an immediate risk to my life.

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I do not have active brain metastases or related conditions.

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I or someone in my family has severe heart disease.

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I have not been treated with AZD9833, SERDs, or fulvestrant before.

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I have lasting side effects from CDK4/6 inhibitor or AI treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neoplasms

Secondary study objectives

Change from baseline in EORTC QLQ-BR23 scale scores

Change from baseline in EORTC QLQ-C30 scale scores

Chemotherapy free survival

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3790

Ribociclib

2018

Completed Phase 3

~2420