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Monoclonal Antibodies

Durvalumab Combination Therapy for Breast Cancer (BEGONIA Trial)

Q: What are some of the most common conditions that Durvalumab is used to manage?

<p>While often used to treat metastatic <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, durvalumab has also been proven effective against other illnesses such as advanced thymoma, <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a>, and malignant neoplasms.</p>

Phase 1 & 2

Recruiting

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

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

BEGONIA Trial 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.Check my eligibility

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.See study design

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.

BEGONIA Trial 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.

BEGONIA Trial Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Laboratory findings

Secondary outcome measures

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%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

BEGONIA 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

Oleclumab

2015

Completed Phase 2

~880

Capivasertib

2021

Completed Phase 1

~130

Paclitaxel

2011

Completed Phase 4

~5380

Trastuzumab deruxtecan

2022

Completed Phase 2

~400

Durvalumab

2017

Completed Phase 2

~3870

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,593,976 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 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

Frequently Asked Questions

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

What is the goal of this research?

"The primary outcome for this trial, as measured by the study sponsor AstraZeneca, will be incidence of adverse events. This data point will be collected over a 3 or 6-month period depending on which part of the study the patient is in. Additionally, secondary outcomes being assessed include objective response rate and duration of response."

Answered by AI

What are some of the most common conditions that Durvalumab is used to manage?

"While often used to treat metastatic bladder cancer, durvalumab has also been proven effective against other illnesses such as advanced thymoma, AIDS, and malignant neoplasms."

Answered by AI

Are people currently signing up to participate in this experiment?

"Unfortunately, this study is not currently enrolling patients. It was originally posted on December 21st, 2018 and has since been edited September 20th, 2022. However, there are plenty of other trials you may be eligible for; There are 4749 studies actively recruiting participants with triple negative breast neoplasms and 1211 for Durvalumab."

Answered by AI

Are elderly people eligible for this experiment?

"This clinical trial only enrolls patients that are between 18-130 years old. There are 407 other studies for minors and 5,672 different trials for senior citizens."

Answered by AI

Are there a lot of hospitals conducting this research in Canada?

"At the moment, this experiment is taking place at 10 different hospitals. The locations are Saint Louis, London and Greenfield Park amongst other places. If you want to make the process more convenient, choose a clinic that is close to your home."

Answered by AI

Might I be eligible to take part in this clinical trial?

"Patients that have been diagnosed with triple negative breast neoplasms and are between 18-130 years old may qualify for this clinical trial. A total of 210 patients will be enrolled in the study."

Answered by AI

Can you provide a list of other scientific investigations that have employed Durvalumab?

"City of Hope Comprehensive Cancer Center hosted the first study on durvalumab in 1997. Since then, there have been 1257 completed clinical trials and 1211 active ones. Many of these studies take place in Saint Louis, Missouri."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

2018. "A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03742102.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer