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Durvalumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Gliwice, PolandBreast CancerDurvalumab - Drug
Eligibility
18 - 130
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 7 Secondary · Reporting Duration: On-study tumor assessments occur every 8 weeks until week 48 (Arms 1-5), every 6 weeks until week 48 (Arms 6-7) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months

Approx. 30 months
Objective response rate (ORR)
Overall survival (OS)
Month 30
Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies
Month 30
Duration of response (DoR)
Month 30
Progression-free survival (PFS).
Month 30
Progression-free survival (PFS 6)
Month 3
Laboratory findings
Month 3
Incidence of adverse events

Trial Safety

Safety Progress

1 of 3

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Side Effects for

DUR + R-CHOP
60%Fatigue
49%Peripheral sensory neuropathy
47%Neutropenia
40%Nausea
28%Diarrhoea
26%Decreased appetite
26%Insomnia
23%Alopecia
23%Headache
23%Dyspnoea
21%Pyrexia
21%Vomiting
21%Constipation
21%Dizziness
21%Dysgeusia
19%Hypokalaemia
19%Cough
19%Stomatitis
16%Anaemia
16%Leukopenia
16%Weight decreased
16%Dry mouth
16%Rash
16%Myalgia
14%Febrile neutropenia
14%Oropharyngeal pain
14%Back pain
12%Oedema peripheral
12%Oral candidiasis
12%Infusion related reaction
12%Abdominal pain upper
9%Fall
9%Thrombocytopenia
9%Urinary tract infection
9%Mucosal inflammation
9%Chills
9%Pruritus
7%Muscle spasms
7%Dry skin
7%Lung infection
7%Hypotension
7%Abdominal pain
7%Pain in extremity
7%Arthralgia
7%Hot flush
7%Vision blurred
7%Nasopharyngitis
7%Hypomagnesaemia
5%Oral herpes
5%General physical health deterioration
5%Dysuria
5%Atrial fibrillation
5%Pneumonia
5%Influenza
5%Infection
2%Pancytopenia
2%Perirectal abscess
2%Spinal pain
2%Pulmonary embolism
2%Erythema
2%Seborrhoeic dermatitis
2%Venous thrombosis
2%Gastrooesophageal reflux disease
2%Tumour pain
2%Deep vein thrombosis
2%Clear cell renal cell carcinoma
2%Cardiac arrest
2%Viral diarrhoea
2%Myocardial ischaemia
2%Autoimmune hepatitis
2%Device related infection
2%Lymphoma
2%Cerebrovascular accident
2%Restless legs syndrome
2%Acute kidney injury
2%Hyponatraemia
2%Histiocytosis haematophagic
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03003520) in the DUR + R-CHOP ARM group. Side effects include: Fatigue with 60%, Peripheral sensory neuropathy with 49%, Neutropenia with 47%, Nausea with 40%, Diarrhoea with 28%.

Trial Design

5 Treatment Groups

Arm 1
1 of 5
Arm 7
1 of 5
Arm 2
1 of 5
Arm 5
1 of 5
Arm 6
1 of 5

Experimental Treatment

210 Total Participants · 5 Treatment Groups

Primary Treatment: Durvalumab · No Placebo Group · Phase 1 & 2

Arm 1Experimental Group · 2 Interventions: Paclitaxel, Durvalumab · Intervention Types: Drug, Drug
Arm 7Experimental Group · 2 Interventions: Datopotamab deruxtecan, Durvalumab · Intervention Types: Drug, Drug
Arm 2Experimental Group · 3 Interventions: Capivasertib, Paclitaxel, Durvalumab · Intervention Types: Drug, Drug, Drug
Arm 5Experimental Group · 3 Interventions: Oleclumab, Paclitaxel, Durvalumab · Intervention Types: Drug, Drug, Drug
Arm 6Experimental Group · 2 Interventions: Trastuzumab deruxtecan, Durvalumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved
Oleclumab
Not yet FDA approved
Capivasertib
Not yet FDA approved
Paclitaxel
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: on-study tumor assessments occur every 8 weeks until week 48 (arms 1-5), every 6 weeks until week 48 (arms 6-7) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,022 Previous Clinical Trials
240,380,997 Total Patients Enrolled
161 Trials studying Breast Cancer
1,237,133 Patients Enrolled for Breast Cancer
Peter Schmid, MD, PhDPrincipal InvestigatorBarts Cancer Institute

Eligibility Criteria

Age 18 - 130 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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