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PARP Inhibitor
Radiosurgery + Olaparib + Immunotherapy for Breast Cancer Brain Metastases (SOLARA Trial)
Phase 1 & 2
Recruiting
Led By Colette Shen, M.D., Ph.D
Research Sponsored by Colette Shen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has histologically confirmed diagnosis of breast cancer per AJCC 8th edition (triple negative [any BRCA status], or HER2-negative with germline or somatic BRCA mutation).
Body weight >30 kg (for durvalumab monotherapy or durvalumab combination).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
SOLARA Trial Summary
This trial is studying if focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, is safe and effective for patients with brain metastases from triple negative or BRCA-mutated breast cancers.
Who is the study for?
This trial is for adults over 18 with breast cancer that has spread to the brain, specifically triple negative or BRCA-mutated types. They should have completed prior cancer treatments at least a week before and recovered from any acute effects except hair loss. Participants need normal organ and bone marrow function, must not be pregnant, agree to use contraception, and have a life expectancy of more than 16 weeks.Check my eligibility
What is being tested?
The study tests focused radiation therapy combined with olaparib (a drug), followed by immunotherapy durvalumab in patients with brain metastases from certain breast cancers. It includes an initial phase where different doses of olaparib are tested alongside radiosurgery, then systemic chemotherapy chosen by the physician plus durvalumab.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood count changes which could increase infection risk or cause anemia/bruising easily; allergic reactions; inflammation in organs like lungs or intestines; headaches or dizziness related to brain treatment.
SOLARA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is either triple negative or HER2-negative with a BRCA mutation.
Select...
I weigh more than 30 kg.
SOLARA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of adverse events
Intracranial Disease control rate
Secondary outcome measures
Extracranial disease progression free survival per RECIST
Extracranial disease progression free survival per iRECIST
Extracranial response rate per RECIST 1.1
+6 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%
Aspartate aminotransferase increased
9%
Dizziness
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
SOLARA Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Treatment ArmExperimental Treatment4 Interventions
Cycle 1 of study treatment will consist of Olaparib twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. Once the subject has recovered from SRS, Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,818 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,298 Patients Enrolled for Breast Cancer
Colette ShenLead Sponsor
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,191,001 Total Patients Enrolled
9 Trials studying Breast Cancer
2,383,389 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have cancer spread beyond the brain without immediate life-threatening symptoms.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I have or had an autoimmune or inflammatory disorder.I have previously received treatments targeting PD-1, PD-L1, or CTLA-4.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I haven't taken immunosuppressive drugs in the last 14 days.I have been diagnosed with a primary immunodeficiency.I am not taking strong or moderate drugs that affect liver enzymes.I do not have any serious ongoing illnesses that could affect my participation in the study.I am willing to follow the safe sex or abstinence guidelines for 3 months after treatment.I have new brain metastasis and am planning to undergo or have undergone specific brain radiation treatments.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I understand and can follow the study's procedures.My breast cancer is either triple negative or HER2-negative with a BRCA mutation.I haven't taken any colony stimulating factors in the last 4 weeks.I have had treatment for spinal cord compression and been stable for 28 days.I have not received a live vaccine in the last 30 days.You have a weakened immune system, for example, if you have HIV.I have had whole brain radiation before, but any brain metastases treated are stable.I finished my last cancer treatment over a week ago and have recovered from its side effects.I have had cancer before, but it was a different type than my current diagnosis.My cancer has spread to the lining of my brain and spinal cord.I cannot have MRI or CT scans regularly.I cannot take pills by mouth or have stomach issues that affect medication absorption.I have signs of bleeding in my brain or risk of brain tissue shift.I had radiation therapy not aimed at the brain within the last 3 weeks, unless it was for symptom relief.Your recent heart test shows uncontrolled heart problems, or you have a condition called congenital long QT syndrome.My organ and bone marrow functions are normal as tested within the last 28 days.I haven't had major surgery in the last 28 days, except for brain surgery or surgery to relieve symptoms.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I am 18 years old or older.I agree to follow strict birth control measures or abstain from sex as required.I need urgent surgery for brain metastases within a week.I weigh more than 30 kg.My condition is rapidly worsening, affecting my internal organs.I may have significant nerve pain or damage.I have had a bone marrow or cord blood transplant in the past.I am not currently using, or have stopped using certain strong medications as required before starting olaparib.I have had cancer treatment but not with PARP inhibitors and immune checkpoint inhibitors at the same time.I have been active and mostly self-sufficient in the last 28 days.I meet the specific requirements set by the drug maker for this trial.I have over 10 untreated brain tumors or their total size is larger than 15cc.I haven't taken any cancer treatment drugs in the last 7 days.I have a history of lung scarring or fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment Arm
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.
How many locations within this city are conducting the research?
"Patients can enroll in this trial at Memorial Sloan Kettering Cancer Center (New york), Duke Cancer Institute (Durham, North carolina) as well as the University of Alabama at Birmingham (Birmingham, Alabama). Additionally, there are 5 other enrolment sites."
Answered by AI
Is Olaparib being trialled in any other medical research projects?
"Currently, 2295 trials are being conducted for Olaparib. 628 of those live experiments have progressed to Phase 3. Guangzhou in Guangdong is the primary city running tests on this medication; however, there are over 100 thousand other locations that also host research efforts concerning Olaparib's efficacy and safety."
Answered by AI
Is recruitment for this trial ongoing?
"Clinicaltrials.gov indicates that this trial is actively recruiting participants, with the initial posting being made on March 9th 2022 and the most recently updated information appearing on October 26th of the same year."
Answered by AI
How many subjects are being investigated in this research?
"This clinical trial necessitates the recruitment of 41 duly qualified participants. Potential candidates can join in from two different centres, such as Memorial Sloan Kettering Cancer Center located in New york and Duke Cancer Institute based out of North carolina."
Answered by AI
What therapeutic applications is Olaparib typically employed for?
"Olaparib is frequently prescribed for metastatic uretero-urothelial carcinoma and has been shown to be useful in treating lymphomas, non-Hodgkin's disease, advanced NSCLC cases, and early stage interventions."
Answered by AI
What goals is the experiment hoping to accomplish?
"This 4-week study seeks to assess Intracranial Disease Control Rate. Secondary objectives include determining the Extracranial Response Rate per iRECIST criteria, Intracranial Progression Free Survival per RANO-BM and Extracranial Response Rates via RECIST 1.1 protocols."
Answered by AI
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