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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until disease progression (up to data cut-off of 29 months)
Awards & highlights

SERENA-2 Trial Summary

This trial is comparing the effectiveness of two different treatments for women with advanced breast cancer. One treatment is a pill, and the other is a shot. The trial will also look at any side effects from these treatments.

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.Check my eligibility
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.See study design
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.

SERENA-2 Trial 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.

SERENA-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Changes From Baseline in Health Related Quality of Life (HRQoL)
Clinical Benefit Rate at 24 Weeks (CBR24)
Duration of Response (DoR)
+5 more
Other outcome measures
Number of Patients With Adverse Events

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803
50%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
HYPERTRIGLYCERIDAEMIA
10%
NAUSEA
10%
PLATELET COUNT DECREASED
10%
CONTUSION
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
DYSPEPSIA
10%
DRY MOUTH
10%
PNEUMONIA
10%
HERPES ZOSTER
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant

SERENA-2 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
4,259 Previous Clinical Trials
288,593,662 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the census of participants in this experiment?

"At present, this clinical trial is not accepting new participants. It was initially posted on April 22nd 2020 and the most recent update to its status occurred on October 19th 2022. If desired, there are 2,282 studies recruiting patients with breast cancer and 133 trials seeking individuals for AZD9833 involvement."

Answered by AI

Has AZD9833 been previously tested in any other medical trials?

"In 2004, AZD9833 was first investigated at Lowell General Hospital. Since then, 89 trials have been concluded and 133 are still in progress; many of these being conducted from Canton, Ohio."

Answered by AI

What therapeutic applications is AZD9833 employed for?

"AZD9833 is frequently employed to treat prior endocrine therapy, as well as a selection of other medical conditions such as disease, breast cancer, and pik3ca gene mutation."

Answered by AI

Which individuals meet the criteria to become part of this research experiment?

"This clinical trial is presently enrolling up to 240 eligible participants, aged 18 and older, with a diagnosis of breast cancer. To be considered for the study, post-menopausal female patients must have an Eastern Cooperative Oncology Group/World Health Organisation performance status rating between 0 and 1; in addition to having experienced progression from their last systemic therapy prior to starting treatment, no more than one line of endocrine therapy or chemotherapy may have been administered."

Answered by AI

Are younger individuals within the age range of 50 years or less being accepted to partake in this trial?

"This medical study is seeking to recruit individuals above the age of consent and below 130 years old."

Answered by AI

Is the enrollment phase of this investigation still ongoing?

"Sadly, this trial has closed recruitment. It was initially posted on April 22nd 2020 and last edited on October 19th 2022. On the other hand, there are 2282 studies recruiting for breast cancer patients and another 133 trials looking for participants with AZD9833 exposure."

Answered by AI

In which geographical areas has this research initiative been launched?

"Currently, 8 separate medical centres are running this trial. Locations in Canton, Lincoln and Chattanooga are available as well as other nearby sites to reduce travel demands for participants."

Answered by AI

What potential adverse effects should be taken into consideration when administering AZD9833?

"Taking into account the Phase 2 trial status of AZD9833, Power's assessment of safety is a score of two. Although there are data confirming its security, efficacy has yet to be demonstrated."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
2020. "A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04214288.
~48 spots leftby Apr 2025
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