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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)

Must not have

Patients with known brain metastases should be excluded from this clinical trial except as those described below, because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

Prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain metastases affecting my participation.

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I have previously been treated with PARP inhibitors or anti-PD-1/PD-L1 antibodies.

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My condition is stable with mild steroid creams.

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I haven't had a severe flare-up of my condition requiring strong treatments in the past year.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I have not received a live flu vaccine within the last 4 weeks.

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I have not had uncontrolled seizures or any seizures in the past year.

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My heart's electrical activity (QTc) is over 470 msec, or I have a family history of long QT syndrome.

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I am not using strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.

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I am not using strong or moderate drugs that affect drug metabolism.

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I have not had a severe infection or been hospitalized for one in the last 4 weeks.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I have not received a live vaccine in the last 4 weeks and do not plan to during or up to 5 months after the study.

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I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.

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I am not pregnant or breastfeeding.

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My brain scans improved after treatment and showed no worsening before my screening.

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My cancer can be measured or seen outside the brain and spinal cord.

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I tested positive for hepatitis C but have no active virus according to my PCR test.

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My cancer has not spread to specific parts of my brain or close to my optic nerves.

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I do not have any serious health issues that are not under control.

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I have had severe side effects from previous immunotherapy.

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My rash covers less than 10% of my body.

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I have never had bleeding in my spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response (DoR)

Overall response rate (ORR)

Other study objectives

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%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 Biopsy

2021

Completed Phase 3

~230

Bone Marrow Aspiration

2011

Completed Phase 2

~1740