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Hormone Therapy

AZD9833 Combinations for Advanced Breast Cancer (SERENA-1 Trial)

Phase 1

Waitlist Available

Led By Richard Baird, MD PhD FRCP

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Documented positive oestrogen receptor status of primary or metastatic tumour tissue, according to the local laboratory parameters

HER-2 negative

Must not have

Uncontrolled hypertension

Intervention with any cytotoxic chemotherapy, investigational agents/other anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of IMP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year).

Awards & highlights

Summary

This trial is testing a new drug, AZD9833, to see if it can shrink tumors in women with a certain type of advanced breast cancer.

Who is the study for?

This trial is for women with advanced breast cancer that's ER positive and HER2 negative. They must be over 18, have had no more than two chemo treatments for advanced disease, and not be on certain drugs or have specific health issues like uncontrolled hypertension or severe systemic diseases. Participants need to agree to contraception if of childbearing potential.

What is being tested?

The study tests AZD9833 alone or combined with other drugs (capivasertib, abemaciclib, ribociclib, anastrozole, palbociclib, everolimus) in different groups to find the best treatment for this type of breast cancer. It's a Phase 1 trial focusing on dosage safety and effectiveness.

What are the potential side effects?

Potential side effects may include reactions related to hormone changes due to estrogen receptor targeting by AZD9833 and its combinations. Other risks could involve common drug-related side effects such as fatigue, nausea, risk of infection from low blood counts but specifics will depend on each drug combination.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is estrogen receptor positive.

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My cancer is not HER2 positive.

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My cancer has spread or returned and doesn't respond to current treatments.

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My cancer has spread or returned and gotten worse after my last treatment.

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I am not pregnant, not breastfeeding, and agree to use effective birth control.

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I have at least one cancer lesion that can be monitored with scans or physical exams.

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My condition allows for two tumor biopsies to be taken.

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I am 18 years old or older.

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My breast cancer is confirmed as adenocarcinoma.

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I can care for myself and have not gotten worse in the past 2 weeks. My doctor thinks I have at least 3 months to live.

Exclusion Criteria

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

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My blood pressure is not controlled by medication.

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I haven't taken any cancer drugs or been in a trial for my advanced breast cancer in the last 14 days.

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

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My cancer has spread to vital organs or the brain, and is not under control.

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I am experiencing symptoms from lung inflammation caused by radiation.

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My blood pressure is very low and not under control.

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My blood tests show my bone marrow or organs aren't working well.

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I am not taking medication that affects my heart's rhythm.

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I do not have severe illnesses like uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.

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My heart's pumping ability is below normal, or I've had specific heart procedures or conditions in the last 6 months.

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I have a history of interstitial lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year).

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The number of subjects with dose-limiting toxicity, as defined in the protocol.

The number of subjects with treatment-related adverse events as assessed by CTCAE v4.03.

Secondary study objectives

Area under the plasma concentration-time curve (AUC) for AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib, Capivasertib, Ribociclib or Anastrozole

Assessment of biomarker changes

Clinical benefit rate at 24 weeks

+7 more

Trial Design

14Treatment groups

Experimental Treatment

Group I: AZD9833 with ribociclib (± anastrozole) dose expansionExperimental Treatment1 Intervention

Group II: AZD9833 with ribociclib (± anastrozole) dose escalationExperimental Treatment1 Intervention

Group III: AZD9833 with palbociclib dose expansionExperimental Treatment1 Intervention

Group IV: AZD9833 with palbociclib dose escalationExperimental Treatment1 Intervention

Group V: AZD9833 with everolimus dose expansionExperimental Treatment1 Intervention

Group VI: AZD9833 with everolimus dose escalationExperimental Treatment1 Intervention

Group VII: AZD9833 with capivasertib dose expansionExperimental Treatment1 Intervention

Group VIII: AZD9833 with capivasertib dose escalationExperimental Treatment1 Intervention

Group IX: AZD9833 with anastrozole dose expansionExperimental Treatment1 Intervention

Group X: AZD9833 with anastrozole dose escalationExperimental Treatment1 Intervention

Group XI: AZD9833 with abemaciclib (± anastrozole)dose expansionExperimental Treatment1 Intervention

Group XII: AZD9833 with abemaciclib (± anastrozole) dose escalationExperimental Treatment1 Intervention

Group XIII: AZD9833 monotherapy dose expansionExperimental Treatment1 Intervention

Group XIV: AZD9833 monotherapy dose escalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD9833 with everolimus

2021

Completed Phase 1

~30

AZD9833

2021

Completed Phase 2

~230

AZD9833 with palbociclib

2021

Completed Phase 1

~30

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,352 Previous Clinical Trials

288,646,413 Total Patients Enrolled

176 Trials studying Breast Cancer

1,245,578 Patients Enrolled for Breast Cancer

Richard Baird, MD PhD FRCPPrincipal InvestigatorBreast Cancer Research Unit, University of Cambridge

Justin Lindemann, MBChB MBAStudy DirectorAstraZeneca

1 Previous Clinical Trials

148 Total Patients Enrolled

Media Library

AZD9833 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03616587 — Phase 1

Breast Cancer Research Study Groups: AZD9833 with capivasertib dose expansion, AZD9833 with anastrozole dose expansion, AZD9833 with ribociclib (± anastrozole) dose expansion, AZD9833 with anastrozole dose escalation, AZD9833 with abemaciclib (± anastrozole) dose escalation, AZD9833 with ribociclib (± anastrozole) dose escalation, AZD9833 with capivasertib dose escalation, AZD9833 with abemaciclib (± anastrozole)dose expansion, AZD9833 monotherapy dose escalation, AZD9833 monotherapy dose expansion, AZD9833 with palbociclib dose escalation, AZD9833 with palbociclib dose expansion, AZD9833 with everolimus dose expansion, AZD9833 with everolimus dose escalation

Breast Cancer Clinical Trial 2023: AZD9833 Highlights & Side Effects. Trial Name: NCT03616587 — Phase 1

AZD9833 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03616587 — Phase 1

~57 spots leftby Sep 2025

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