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Checkpoint Inhibitor
Atezolizumab + Stereotactic Radiation for Breast Cancer with Brain Tumor
Phase 2
Waitlist Available
Led By Nancy U Lin, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2
Participants must have normal organ and marrow function as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years
Awards & highlights
Study Summary
This trial is testing whether the combination of atezolizumab and SRS is more effective in treating triple-negative breast cancer that has spread to the brain, than SRS alone.
Who is the study for?
This trial is for adults with triple-negative breast cancer that has spread to the brain. They must have stable brain metastases treatable with SRS, controlled steroid use, measurable disease outside the brain, and normal organ function. Pregnant women or those on high-dose steroids, previous anti-PD-1/PD-L1 therapy, or with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests combining atezolizumab (a drug) with stereotactic radiosurgery (SRS), a precise radiation procedure for treating brain tumors in patients whose breast cancer has spread to the brain.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions like inflammation of organs, infusion reactions similar to allergic responses, fatigue and potential lung issues. SRS can lead to headaches, swelling around the treatment area and temporary hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My organs and bone marrow are functioning normally.
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I do not have more than 5 new brain lesions needing focused radiation.
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My cancer can be measured by scans outside of my brain.
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My cancer is triple-negative.
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I have brain metastases and need stereotactic radiosurgery.
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My brain tumor is clearly defined and no larger than 3.0 cm.
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I am 18 years old or older.
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My side effects from cancer treatment are mild.
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My breast cancer is confirmed to be at stage IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from the first dose of atezolizumab to the date of death from any cause or date last known alive, for a maximum of 3.8 years
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
Secondary outcome measures
Extracranial Objective Response Rate
Overall Survival
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab + Stereotactic radiosurgery (SRS)Experimental Treatment2 Interventions
Atezolizumab administered intravenously once every 3 weeks
Stereotactic radiosurgery (SRS) begin within 14 days after brain MRI obtained
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,971 Total Patients Enrolled
141 Trials studying Breast Cancer
22,611 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,137 Total Patients Enrolled
96 Trials studying Breast Cancer
23,212 Patients Enrolled for Breast Cancer
Nancy U Lin, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I've been on a stable dose of dexamethasone (2mg or less) for at least a week.My organs and bone marrow are functioning normally.I understand the study requirements and have signed the consent form.I have a serious illness that is not under control.My cancer has spread to the brain or its coverings.I haven't taken high doses of steroids like dexamethasone (>2mg/day) in the last week.I am on long-term steroids or other drugs that weaken my immune system.I am being treated with steroids for lung inflammation not caused by an infection.I do not have more than 5 new brain lesions needing focused radiation.My cancer can be measured by scans outside of my brain.I stopped any systemic cancer treatments 14 days before starting the new therapy.I cannot have MRI scans with gadolinium contrast or IV contrast.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My cancer is triple-negative.I have brain metastases and need stereotactic radiosurgery.My brain tumor is clearly defined and no larger than 3.0 cm.I am 18 years old or older.I've had brain surgery or radiation but my current brain cancer can be treated with focused radiation.I have taken a pregnancy test recently and it was negative.I have no history of cancer, except for certain exceptions.My side effects from cancer treatment are mild.You have had a bad reaction to drugs similar to atezolizumab.You have HIV, Hepatitis B, or Hepatitis C.I need urgent brain surgery due to complications.I can start or keep taking bisphosphonate therapy during the study.My breast cancer is confirmed to be at stage IV.I have had multiple treatments for my condition.I have not received a live vaccine in the last 28 days.I agree to have two research biopsies if my cancer outside the brain can be safely accessed.I have a history of lung scarring or fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab + Stereotactic radiosurgery (SRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities available for willing participants in this clinical trial?
"This clinical trial is not accepting any new participants at present. The information was initially published on the 1st of May 2018 and last updated on 15th August 2022. For those seeking additional medical trials, there are currently 3009 studies recruiting breast cancer patients and 351 trials searching for individuals to participate in experiments regarding Atezolizumab."
Answered by AI
Has there been any precedent for this kind of research?
"Since 2008, Hoffmann-La Roche has sponsored research into the efficacy of atezolizumab. The initial study had a sample size of 720 and resulted in phase 2 approval for this drug. Nowadays, over 350 active trials are located across 1645 cities and 74 nations worldwide."
Answered by AI
What is the current size of the participant pool for this research?
"Unfortunately, this research project is no longer recruiting. After being published on May 1st of 2018 and last modified on August 15th 2022, the trial has been closed to new participants. However, there are still 3009 studies looking for those affected by breast cancer and 351 trials involving Atezolizumab that are open to enrollment."
Answered by AI
For what maladies is Atezolizumab a common course of treatment?
"Atezolizumab is typically prescribed to combat small cell lung cancer (SCLC). However, it can also be used in the management of postoperative malignant neoplasms and non-small cell lung carcinoma."
Answered by AI
Has Atezolizumab been officially sanctioned for medical use by the FDA?
"Our evaluation of Atezolizumab's safety was a 2, since the Phase 2 trial has only yielded supportive data for its safeguarding properties but no evidence demonstrating efficacy."
Answered by AI
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