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Checkpoint Inhibitor
Durvalumab + Tremelimumab for Breast Cancer
Phase < 1
Waitlist Available
Led By Jennifer K Litton
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Female subjects must either be of non-reproductive potential or must have a negative urine pregnancy test upon study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects of two immunotherapy drugs given before surgery to patients with hormone receptor positive, HER2 negative stage II-III breast cancer.
Who is the study for?
This trial is for women with hormone receptor positive, HER2 negative stage II-III breast cancer without metastasis. Participants must have adequate organ function, no history of severe allergies to the drugs being tested or immunodeficiency, and not be pregnant or breastfeeding. They should not have used any PD1 or PD-L1 inhibitors like durvalumab or anti-CTLA4 like tremelimumab before.Check my eligibility
What is being tested?
The trial is testing the effects of two monoclonal antibodies, durvalumab and tremelimumab, given before surgery to see if they can help the immune system fight breast cancer more effectively. It's an early phase I study focusing on side effects and how tumor cells respond.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions where the drug enters the body, fatigue, digestive issues such as diarrhea or colitis, liver inflammation, hormonal gland problems like thyroid disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am not pregnant or cannot become pregnant.
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My breast cancer is hormone receptor positive, HER2 negative, and is in stage II-III without spread to other parts.
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I am scheduled for chemotherapy before surgery.
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My kidneys are functioning well enough to filter waste.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of Enrolling 15 Patients Within 2 Years
Safety and Tolerability of Tremelimumab Plus Durvalumab in Participants With HR+/HER2 Neg Breast Cancer.
Secondary outcome measures
Change in immune and molecular measures in peripheral blood
Change in immune and molecular measures in tumor tissue
Other outcome measures
Pathologic response
Side effects data
From 2019 Phase 2 trial • 33 Patients • NCT0300740738%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tremelimumab, durvalumab)Experimental Treatment2 Interventions
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo a biopsy and receive standard of care neoadjuvant chemotherapy before undergoing surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,651 Total Patients Enrolled
25 Trials studying Progesterone Receptor Positive
5,636 Patients Enrolled for Progesterone Receptor Positive
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,786 Total Patients Enrolled
3 Trials studying Progesterone Receptor Positive
121 Patients Enrolled for Progesterone Receptor Positive
Jennifer K LittonPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an autoimmune disease in the last 2 years.I am willing and able to follow the study's requirements, including treatments and visits.Your heart takes too long to recover between beats.I have not received a live vaccine within the last 30 days.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.I am fully active or can carry out light work.You need to have a hemoglobin level of 9.0 grams per deciliter or higher.Your bilirubin level is not too high, unless you have Gilbert's syndrome.I have never been treated with PD1, PD-L1 inhibitors, or anti-CTLA4 drugs.I have or had inflammatory bowel disease.I do not have any severe illnesses that my doctors are still trying to get under control.I have had cancer spread to the lining of my brain and spinal cord.I have seizures that are not controlled by medication.I am not pregnant or cannot become pregnant.You have received an organ from someone else in the past.Your platelet count is at least 100,000 per cubic millimeter.You have a history of a weak immune system from birth.I have been diagnosed with tuberculosis in the past.Your body has enough white blood cells called neutrophils.My breast cancer is hormone receptor positive, HER2 negative, and is in stage II-III without spread to other parts.I have had cancer before, but it fits the exceptions.My liver function tests are within the required range.I am scheduled for chemotherapy before surgery.I haven't taken immunosuppressive drugs in the last 28 days.My kidneys are functioning well enough to filter waste.You have had a bad reaction to durvalumab or tremelimumab, or any ingredients in these medications.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tremelimumab, durvalumab)
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.
Has this medical trial been conducted previously?
"The investigation of Tremelimumab dates all the way back to 2007 when AstraZeneca launched their first clinical trial. Following its initial success, Phase 2 approval was granted and currently there are 340 ongoing trials occurring in 1327 cities across 58 countries."
Answered by AI
Are there any vacancies in this medical experiment at the moment?
"Clinicaltrials.gov reports that this medical trial is presently not enrolling candidates, as the study was last edited on August 18th 2022. However, there are 2631 other clinical trials open for enrollment at the moment."
Answered by AI
To what extent has Tremelimumab been investigated in past clinical experiments?
"Currently, there are 340 ongoing studies for Tremelimumab with 51 trials in the advanced phase 3 stage. Though most of these research projects are based out of Taipei and Tennessee, it is being carried out at over 13 thousand locations worldwide."
Answered by AI
What is the cap for enrollment in this clinical trial?
"Unfortunately, this clinical trial is no longer in the process of recruiting patients. It was first made public on June 13th 2017 and ceased to accept new participants August 18th 2022. If you are searching for other studies, there are currently 2291 trials involving breast cancer and 340 trials with Tremelimumab that still have open slots."
Answered by AI
What is Tremelimumab typically used to treat?
"Tremelimumab is a successful treatment for unresectable stage III non-small cell lung cancer, yet it also has practical applications when treating metastatic ureter urothelial carcinoma and other advanced directives."
Answered by AI
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