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Checkpoint Inhibitor

Olaparib +/− Atezolizumab for Advanced Breast Cancer

Phase 2
Waitlist Available
Led By Patricia M LoRusso
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear when performed as clinically indicated
A stable regimen of highly active anti-retroviral therapy (HAART)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study Summary

This trial is testing olaparib with or without atezolizumab to treat non-HER2-positive breast cancer that has spread and is not able to be surgically removed or has metastasized.

Who is the study for?
Adults with non-HER2-positive breast cancer that's locally advanced, unresectable, or metastatic and have a BRCA mutation. They must not be on certain medications, have measurable disease, good organ function, no major surgery within the last 28 days, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Olaparib alone or combined with Atezolizumab in treating patients. Olaparib blocks enzymes that repair cancer cell DNA while Atezolizumab helps the immune system attack the tumor. The study aims to see which treatment works better.See study design
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, anemia and other blood-related issues. Atezolizumab can lead to immune-related side effects like inflammation of organs but also common symptoms such as tiredness and potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests do not show signs of MDS or AML.
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I am on a stable HIV medication regimen.
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I have a tumor that can be measured with imaging or physical exam.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My kidneys are functioning well.
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My LH and FSH levels indicate I am post-menopausal, even though I am under 50.
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I had my ovaries removed due to radiation and my last period was over a year ago.
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I can take pills and don't have vomiting or stomach issues that affect medication absorption.
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I have had surgery to remove my ovaries or uterus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

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 (PFS)
Secondary outcome measures
Duration of response (DoR)
Overall response rate (ORR)
Other outcome measures
Body Weight Changes
Change in PD-L1
Change in level of tumor infiltrating lymphocytes (TILs)
+2 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (olaparib, atezolizumab)Experimental Treatment12 Interventions
Patients receive olaparib as in Arm I and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, bone scan, and/or PET scan as well as a biopsy and blood sample collection throughout the trial. Patients may also undergo a bone marrow aspiration and biopsy on study.
Group II: Arm I (olaparib)Experimental Treatment11 Interventions
Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to Arm II. Patients undergo an x-ray, CT scan, MRI, bone scan, and/or PET scan as well as a biopsy and blood sample collection throughout the trial. Patients may also undergo a bone marrow aspiration and biopsy on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Olaparib
2007
Completed Phase 4
~2140
Positron Emission Tomography
2008
Completed Phase 2
~2260
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,608 Previous Clinical Trials
40,915,447 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
261 Total Patients Enrolled

Frequently Asked Questions

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

Is Olaparib a new medication?

"548 clinical trials are currently underway to study Olaparib. 99 of those trials are in the critical third stage. The majority of these studies originate from New york, but there are 27896 locations running experiments for this treatment across the globe."

Answered by AI

Does this clinical trial break new ground in the medical field?

"548 clinical trials for Olaparib are recruiting patients in 2161 different cities, located across 75 countries. The first ever study was completed in 2005 and involved 98 individuals. That initial research project cleared Phase 1 drug approval thanks to the sponsoring from AstraZeneca. In the 16 years since then, 321 more studies have been carried out."

Answered by AI

At how many different physical sites can patients participate in this trial?

"This trial is based out of Moffitt Cancer Center-International Plaza in Tampa, Florida, University of Colorado Hospital in Aurora, Colorado, and Smilow Cancer Hospital Care Center-Fairfield in Fairfield, Connecticut with 36 other satellite locations."

Answered by AI

What is the official stance of the FDA on Olaparib?

"Olaparib has received a safety score of 2. This is due to it being a Phase 2 trial, where there is evidence suggesting it is safe but not necessarily effective."

Answered by AI

What is the approved use for Olaparib?

"Olaparib has shown to be an effective mode of pharmacotherapy for small cell lung cancer (sclc) and malignant neoplasms."

Answered by AI

Are there any open positions in this clinical trial for new patients?

"This particular clinical trial is no longer looking for patients. The first posting was on November 15th, 2016 and the last edit was September 2nd, 2022. There are 4728 other trials currently searching for breast cancer patients and 548 trials specifically for Olaparib that have open recruitment."

Answered by AI
~5 spots leftby Aug 2024