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Selective Estrogen Receptor Degrader (SERD)

AZD9833 vs Fulvestrant for Advanced Breast Cancer (SERENA-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior endocrine therapy as follows: Recurrence or progression on at least one line of endocrine therapy
No more than 1 line of endocrine therapy for advanced disease
Must not have
Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system metastatic disease
Radiotherapy with a limited field of radiation for palliation within 1 week of dosing, or to > 30% of bone marrow or a wide field within 4 weeks of dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until disease progression (up to data cut-off of 29 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial compares a new pill (AZD9833) with an existing injection for treating advanced breast cancer in post-menopausal women. It targets women with a specific type of breast cancer that relies on estrogen to grow. Both treatments work by blocking estrogen receptors to slow down or stop cancer growth.

Who is the study for?
This trial is for post-menopausal women aged at least 18 with advanced ER-positive HER2-negative breast cancer. They must have had recurrence or progression after endocrine therapy, possibly including CDK4/6 inhibitors, and no more than one chemotherapy for advanced disease. No prior fulvestrant/SERD treatment, good performance status (ECOG/WHO 0-1), and measurable disease are required.
What is being tested?
The study compares the effectiveness and safety of a new oral drug called AZD9833 against an existing intramuscular drug named Fulvestrant in treating advanced breast cancer. It's a Phase 2 trial where participants are randomly assigned to either treatment group.
What are the potential side effects?
Potential side effects may include reactions related to hormone therapies such as hot flashes, injection site pain from Fulvestrant, nausea, fatigue, bone pain, and possible blood clots. Side effects specific to AZD9833 aren't detailed but could be similar due to its action on estrogen receptors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer returned or worsened after endocrine therapy.
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I have had only one hormone therapy for my advanced disease.
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I am fully active or can carry out light work.
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I am a woman over 18 and have gone through menopause.
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I have had only one chemotherapy treatment for my advanced disease.
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My breast cancer has spread, is ER-positive, and HER2-negative.
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I have not been treated with fulvestrant or similar hormone therapies.
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I have a tumor that can be measured or a bone lesion that has not been treated with radiation.

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 or my brain and is not under control.
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I haven't had extensive radiation therapy recently.
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My bone marrow or organs are not functioning well.
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I have not had major surgery or significant injury recently.
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I am not taking medication that affects my heart's rhythm.
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My heart health does not meet specific criteria due to issues like abnormal heart rhythms or blood pressure problems.
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I don't have ongoing severe nausea, vomiting, major gut surgery, or diseases that affect food absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until disease progression (up to data cut-off of 29 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until disease progression (up to data cut-off of 29 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 (PFS)
Secondary study objectives
Changes From Baseline in Health Related Quality of Life (HRQoL)
Clinical Benefit Rate at 24 Weeks (CBR24)
Duration of Response (DoR)
+5 more
Other study objectives
Number of Patients With Adverse Events

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: AZD9833 Dose CExperimental Treatment1 Intervention
The patients will receive AZD9833 (Dose C).
Group II: AZD9833 Dose BExperimental Treatment1 Intervention
The patients will receive AZD9833 (Dose B).
Group III: AZD9833 Dose AExperimental Treatment1 Intervention
The patients will receive AZD9833 (Dose A).
Group IV: Fulvestrant 500 mgActive Control1 Intervention
The patients will receive Fulvestrant (500 mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9833
2021
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,353 Total Patients Enrolled
177 Trials studying Breast Cancer
1,245,073 Patients Enrolled for Breast Cancer

Media Library

AZD9833 (Selective Estrogen Receptor Degrader (SERD)) Clinical Trial Eligibility Overview. Trial Name: NCT04214288 — Phase 2
Breast Cancer Research Study Groups: AZD9833 Dose A, AZD9833 Dose C, Fulvestrant 500 mg, AZD9833 Dose B
Breast Cancer Clinical Trial 2023: AZD9833 Highlights & Side Effects. Trial Name: NCT04214288 — Phase 2
AZD9833 (Selective Estrogen Receptor Degrader (SERD)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04214288 — Phase 2
~43 spots leftby Dec 2025
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