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Monoclonal Antibodies

Durvalumab Combination Therapy for Breast Cancer (BEGONIA Trial)

Phase 1 & 2
Waitlist Available
Led By Peter Schmid, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients enrolled to Arm 6 (durvalumab and DS-8201a) must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
At least 18 years of age at the time of screening
Must not have
Untreated CNS metastases
Active or prior documented autoimmune or inflammatory disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on-study tumor assessments occur every 8 weeks until week 48 (arms 1-5), every 6 weeks until week 48 (arms 6-8) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of durvalumab, a new immunotherapy drug, in combination with other cancer treatments, for people with first-line metastatic triple negative breast cancer.

Who is the study for?
This trial is for adult women with metastatic triple negative breast cancer (TNBC) who haven't had treatment for stage IV TNBC. They must have a measurable lesion, be in good physical condition (WHO/ECOG 0 or 1), and meet specific criteria based on their tumor's characteristics like HER2 low expression or PD-L1 positivity, depending on the study arm they're eligible for.
What is being tested?
The trial tests the safety and effectiveness of durvalumab combined with new cancer therapies, with or without paclitaxel. It aims to find better first-line treatments for metastatic TNBC by comparing different drug combinations across multiple groups.
What are the potential side effects?
Potential side effects include allergic reactions to medication components, infection risks due to immune system suppression, possible heart issues such as QTc prolongation leading to arrhythmias, lung problems like interstitial lung disease/pneumonitis, and blood sugar management difficulties if diabetic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My triple-negative breast cancer is advanced, can't be surgically removed, and has low HER2.
Select...
I am 18 years old or older.
Select...
I have at least one tumor that can be measured and has not been treated with radiation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am female.
Select...
My tumor is PD-L1 positive as confirmed by a specific test.
Select...
I have not received any treatment for stage IV triple-negative breast cancer.
Select...
My breast cancer cannot be removed by surgery and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have brain metastases that have not been treated.
Select...
I have or had an autoimmune or inflammatory disorder.
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I have previously been treated with PI3K, AKT, or mTOR inhibitors.
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I don't have heart issues or family history that could affect my heart's rhythm.
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I haven't taken chloroquine or hydroxychloroquine in the last 14 days.
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My heart's pumping ability is below 50%.
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I am not pregnant or breastfeeding.
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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.
Select...
I am not currently on any chemotherapy, immunotherapy, or biological therapy for cancer.
Select...
I have diabetes (Type 1 or Type 2) and need insulin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-study tumor assessments occur every 8 weeks until week 48 (arms 1-5), every 6 weeks until week 48 (arms 6-8) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and on-study tumor assessments occur every 8 weeks until week 48 (arms 1-5), every 6 weeks until week 48 (arms 6-8) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 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
Incidence of adverse events
Laboratory findings
Secondary study objectives
Duration of response (DoR)
Objective response rate (ORR)
Overall survival (OS)
+4 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Awards & Highlights

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

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm 8Experimental Treatment2 Interventions
durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)
Group II: Arm 7Experimental Treatment2 Interventions
durvalumab + datopotamab deruxtecan
Group III: Arm 6Experimental Treatment2 Interventions
durvalumab + trastuzumab deruxtecan
Group IV: Arm 5Experimental Treatment3 Interventions
durvalumab + paclitaxel + oleclumab
Group V: Arm 2Experimental Treatment3 Interventions
durvalumab + paclitaxel + capivasertib
Group VI: Arm 1Experimental Treatment2 Interventions
durvalumab + paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Capivasertib
2021
Completed Phase 1
~130
Oleclumab
2015
Completed Phase 2
~880
Paclitaxel
2011
Completed Phase 4
~5450
Trastuzumab deruxtecan
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,413 Total Patients Enrolled
175 Trials studying Breast Cancer
1,243,071 Patients Enrolled for Breast Cancer
Peter Schmid, MD, PhDPrincipal InvestigatorBarts Cancer Institute

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03742102 — Phase 1 & 2
Breast Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03742102 — Phase 1 & 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03742102 — Phase 1 & 2
Breast Cancer Research Study Groups: Arm 8, Arm 1, Arm 7, Arm 2, Arm 5, Arm 6
~0 spots leftby Nov 2024
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