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Selective Estrogen Receptor Degrader

Saruparib + Camizestrant for Breast Cancer (EvoPAR-BR01 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

FFPE tumour tissue from each participant

Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease

Must not have

Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study

Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 88 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial aims to see how well a combination of saruparib and camizestrant works compared to a standard treatment in patients with a specific type of advanced breast cancer."

Who is the study for?

This trial is for adults with advanced breast cancer that's HR-positive, HER2-negative, and has specific mutations (BRCA1, BRCA2, or PALB2). Participants should have good organ function and an ECOG performance status of 0 or 1. They must not have had certain treatments recently and should be able to swallow pills. People with severe nausea, GI diseases, bleeding disorders, active infections like HIV or hepatitis B/C, heart issues, or those on conflicting medications can't join.

What is being tested?

The study tests the effectiveness of Saruparib (AZD5305) combined with Camizestrant against standard CDK4/6 inhibitors plus endocrine therapy in treating advanced breast cancer. It aims to see if this new combination works better for patients who haven't responded well to other treatments.

What are the potential side effects?

Potential side effects may include nausea and vomiting from the medication itself; blood-related issues such as anemia; fatigue; possible liver enzyme changes indicating liver function impact; hormonal changes due to endocrine therapy; and potential interactions leading to heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

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

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My tumor tissue is stored in a specific way for testing.

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My breast cancer cannot be cured with surgery or has spread to other parts.

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My breast cancer is HR-positive and HER2-negative.

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I can care for myself and have not gotten worse in the past 2 weeks.

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I have a genetic mutation in BRCA1, BRCA2, or PALB2.

Exclusion Criteria

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

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I haven't had major surgery or a serious injury in the last 4 weeks and don't expect to need major surgery during the study.

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I do not have any severe illnesses or uncontrolled infections.

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I have severe, ongoing nausea or a chronic stomach condition that makes it hard for me to swallow pills.

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I have had recent palliative radiotherapy.

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I am prone to bleeding easily.

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I have a history of or signs pointing to a blood disorder like MDS or AML.

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I have an active and uncontrolled HIV infection.

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I do not have an active tuberculosis infection.

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I am currently on hormone therapy for conditions not related to cancer.

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I have a history of severe low blood cell counts that didn't improve.

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I do not have cancer spread to my brain, spinal cord, or its coverings.

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I have had another type of cancer.

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I have lasting side effects from cancer treatment, but not hair loss.

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I am not on any other cancer treatments right now.

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I haven't taken strong medication or herbal supplements that affect liver enzymes recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 88 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 88 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 88 months 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

Secondary study objectives

Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)

Duration of Response

Objective Response Rate

+6 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3: Physician's choice CDK4/6i plus camizestrantExperimental Treatment4 Interventions

participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines

Group II: Arm 1: saruparib (AZD5305) plus camizestrantExperimental Treatment2 Interventions

participants will receive saruparib (AZD5305) orally and camizestrant orally

Group III: Arm 2: Physician's choice CDK4/6i plus physician's choice ETActive Control7 Interventions

agents are indicated below and should follow local guidelines: * Physician's Choice CDK4/6i: * abemaciclib orally, or * ribociclib orally, or * palbociclib orally. * Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Palbociclib

2017

Completed Phase 3

~3790