What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Selective Estrogen Receptor Degraders (SERDs) like Camizestrant and CDK4/6 inhibitors like Palbociclib, have specific side effects. SERDs can cause hot flashes, fatigue, nausea, and joint pain. CDK4/6 inhibitors are associated with neutropenia, infections, fatigue, nausea, diarrhea, and hair thinning. Patients should discuss these potential side effects with their healthcare providers to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that are similar to the combination of camizestrant and palbociclib. Palbociclib, a CDK4/6 inhibitor, is already FDA-approved and is commonly used in combination with endocrine therapies such as letrozole or fulvestrant for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Other CDK4/6 inhibitors approved by the FDA include ribociclib and abemaciclib, which are also used in combination with endocrine therapies. Fulvestrant, a selective estrogen receptor degrader (SERD), is another FDA-approved drug used in combination with CDK4/6 inhibitors for similar indications.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Elacestrant (another selective estrogen receptor degrader) which has shown efficacy in clinical trials for ER-positive, HER2-negative breast cancer. 2) Abemaciclib and Ribociclib (other CDK4/6 inhibitors) which are already approved and have demonstrated effectiveness in combination with endocrine therapy. 3) Alpelisib (a PI3K inhibitor) for patients with PIK3CA-mutated breast cancer, offering a targeted approach. 4) Sacituzumab Govitecan (an antibody-drug conjugate) which has shown promise in treating metastatic triple-negative breast cancer and may have potential in other subtypes.

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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

Must not have

Have uncontrolled cancer that has spread to the brain or the spinal cord

Active infection including tuberculosis, HBV and HCV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 24 weeks post progression (up to approximately 5 years)

Awards & highlights

Pivotal Trial

Summary

This trial is comparing two drug combinations to treat a specific type of advanced breast cancer. One combination includes a new drug called camizestrant, and the other includes anastrozole. Both combinations also use palbociclib. The goal is to see which combination works better at slowing down the 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.

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.

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.

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.

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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.

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 my brain or spinal cord and is not under control.

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I do not have an active infection like TB, hepatitis B, or hepatitis C.

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I do not have major health issues like TB, HIV, heart problems, or a kidney transplant that could affect my trial participation.

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I do not have active brain metastases or related conditions.

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I have not taken AZD9833, fulvestrant, or similar experimental drugs.

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

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My cancer returned within a year after treatment.

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I am not currently receiving any cancer treatments.

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I have heart disease that affects my daily life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 24 weeks post progression (up to approximately 5 years)

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

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

Primary study objectives

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1

Secondary study objectives

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

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 + 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

~3790

AZD9833

2021

Completed Phase 2

~230

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective Estrogen Receptor Degraders (SERDs) like Camizestrant bind to estrogen receptors on breast cancer cells, causing receptor degradation and inhibiting estrogen-driven cell proliferation. CDK4/6 inhibitors such as Palbociclib block cyclin-dependent kinases 4 and 6, essential for cell cycle progression, thereby preventing cancer cell division and growth. These targeted mechanisms are crucial for breast cancer patients as they offer more effective and personalized treatment options with potentially fewer side effects compared to traditional chemotherapy.