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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 belowSelect...
My breast cancer is at stage IV and has been confirmed by tests.
Select...
I have a genetic mutation in a DNA repair gene, but not in BRCA1 or BRCA2.
Select...
I have not failed more than two chemotherapy treatments for my advanced cancer.
Select...
I have received specific previous treatments for my cancer, including chemotherapy.
Select...
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:Select...
I have not had major surgery in the last 2 weeks.
Select...
I am not taking strong or moderate drugs that affect liver enzyme activity.
Select...
I have lasting side effects from cancer treatment, but not hair loss.
Select...
I have a BRCA1 or BRCA2 gene mutation.
Select...
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
Select...
My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.
Select...
I have never been treated with a PARP inhibitor like olaparib.
Select...
I have brain metastases that are not under control and cause symptoms.
Select...
I have had a bone marrow or cord blood transplant in the past.
Select...
I cannot take pills by mouth or have stomach issues that affect medication absorption.
Select...
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
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 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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
9%
Hyperglycaemia
9%
Dizziness
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
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%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
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%
General physical health deterioration
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%
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
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
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 III: OLAPARIB QD GERMLINE 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 measurement q6 weeks x 24 weeks, then q 12 weeks
Group IV: OLAPARIB QD GERMLINE MUTATIONExperimental 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 measurement q6 weeks x 24 weeks, then q 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,712 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,559 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,497 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,113 Previous Clinical Trials
358,767 Total Patients Enrolled
Nadine Tung, MDPrincipal Investigator - Beth Israel Deaconess Medical Center
Associated Physicians of Hmfp@Bidmc, Beth Israel Deaconess Medical Center
Harvard Medical Sch (Medical School)
Beth Israel Deaconess Hp M C (Residency)
2 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is at stage IV and has been confirmed by tests.I have a genetic mutation in a DNA repair gene, but not in BRCA1 or BRCA2.I have not failed more than two chemotherapy treatments for my advanced cancer.I have received specific previous treatments for my cancer, including chemotherapy.I haven't had cancer in the last 5 years, except for certain types that were fully treated.My organ and bone marrow functions are normal.I have not had major surgery in the last 2 weeks.I am not taking strong or moderate drugs that affect liver enzyme activity.I do not have any serious, uncontrolled health issues or infections.I have lasting side effects from cancer treatment, but not hair loss.I have a BRCA1 or BRCA2 gene mutation.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.I have had brain metastases, but they have been treated.I am eligible for this study regardless of my gender.I have never been treated with a PARP inhibitor like olaparib.I have brain metastases that are not under control and cause symptoms.I have had a bone marrow or cord blood transplant in the past.I cannot take pills by mouth or have stomach issues that affect medication absorption.I am willing and able to follow the study's treatment and visit schedule.I do not have active hepatitis B or C.You are allergic to olaparib or any of the ingredients in the product.I have a tumor that can be measured and monitored over time.I have not received a blood transfusion in the last 4 months.You have a weakened immune system, for example, if you have HIV.I have a BRCA1 or BRCA2 mutation but no inherited BRCA mutation, confirmed by a certified lab.
Research Study Groups:
This trial has the following groups:- Group 1: OLAPARIB QD GERMLINE MUTATION
- Group 2: OLAPARIB QD GERMLINE MUTATION - EXPANSION
- Group 3: OLAPARIB QD SOMATIC MUTATION
- Group 4: OLAPARIB QD SOMATIC MUTATION - EXPANSION
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.