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PARP Inhibitor

Olaparib for Metastatic Breast Cancer

Phase 2

Waitlist Available

Led By Nadine Tung, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed invasive breast cancer with stage IV disease, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study.

Patients must have documented germline or somatic mutation in one of the DNA repair genes listed, with no germline BRCA1 or BRCA2 mutation.

Must not have

Major surgery within 2 weeks of starting study treatment.

Concomitant use of known strong or moderate CYP3A inhibitors or inducers.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with metastatic breast cancer who have an altered gene that suggests the tumor may not be able to repair its genetic material. The study will evaluate whether the drug Olaparib is effective in treating the cancer.

Who is the study for?

This trial is for adults with metastatic breast cancer that has spread beyond the breast and have specific gene mutations (excluding BRCA1/2). Participants must have normal organ/bone marrow function, no more than two prior chemotherapy regimens for metastasis, not be pregnant or breastfeeding, able to take oral medication, and willing to follow study procedures.

What is being tested?

The trial tests Olaparib's effectiveness in patients whose tumors are sensitive due to certain genetic mutations. Olaparib is a PARP inhibitor which may help treat cancer by exploiting the tumor's impaired DNA repair ability. The study includes those with inherited or tumor-only mutations.

What are the potential side effects?

Olaparib can cause side effects like nausea, vomiting, fatigue, anemia (low red blood cells), neutropenia (low white blood cells), thrombocytopenia (low platelets), diarrhea, indigestion, headache, taste changes and decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is at stage IV and has been confirmed by tests.

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I have a genetic mutation in a DNA repair gene, but not in BRCA1 or BRCA2.

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I have not failed more than two chemotherapy treatments for my advanced cancer.

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I have received specific previous treatments for my cancer, including chemotherapy.

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I have a tumor that can be measured and monitored over time.

Exclusion Criteria

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

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I have not had major surgery in the last 2 weeks.

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I am not taking strong or moderate drugs that affect liver enzyme activity.

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I have lasting side effects from cancer treatment, but not hair loss.

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I have a BRCA1 or BRCA2 gene mutation.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.

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I have never been treated with a PARP inhibitor like olaparib.

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I have brain metastases that are not under control and cause symptoms.

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I have had a bone marrow or cord blood transplant in the past.

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I cannot take pills by mouth or have stomach issues that affect medication absorption.

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I do not have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate

Secondary study objectives

Clinical Benefit Rate

Mutant Allele Frequency

Number of Participants with Severe Adverse Events

+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

4Treatment groups

Experimental Treatment

Group I: OLAPARIB QD SOMATIC MUTATION - EXPANSIONExperimental Treatment1 Intervention

After the screening procedures confirm eligibility to participate in the research study: * Olaparib: Each study treatment cycle lasts 21 days (3 weeks), taking 2 times per day, 12 hours apart. * Tumor measurements q6 weeks x 24 weeks, then q 12 weeks

Group II: OLAPARIB QD SOMATIC MUTATIONExperimental Treatment1 Intervention

Group III: OLAPARIB QD GERMLINE MUTATION - EXPANSIONExperimental Treatment1 Intervention

Group IV: OLAPARIB QD GERMLINE MUTATIONExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

0 / 16Eligibility criteria met