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Olaparib for Breast Cancer

Phase 1
Waitlist Available
Led By Maysa Abu-Khalaf, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of olaparib when given with hyperthermia, which is a treatment that raises the temperature of the body to kill cancer cells, in patients with breast cancer that has come back in the chest wall.

Eligible Conditions
  • Breast Cancer
  • Chest Wall Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Best local overall response rate (ORR)
Local progression free-survival (PFS)
PFS
+2 more
Other outcome measures
BRCA1/2 expression patterns
Deoxyribonucleic acid (DNA) damage
Homologous recombination (HR) capacity

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
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, hyperthermia)Experimental Treatment4 Interventions
Patients receive olaparib PO BID. Treatment continues for 4 weeks in the absence of disease progression and unacceptable toxicity. Beginning week 2, patients also undergo hyperthermia treatment over 1 hour twice weekly for 3 weeks in the absence of disease progression and unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Hyperthermia Treatment
2013
N/A
~10

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,986 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,274 Previous Clinical Trials
288,613,418 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Maysa Abu-Khalaf, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Breast Cancer
100 Patients Enrolled for Breast Cancer

Media Library

Hyperthermia Treatment Clinical Trial Eligibility Overview. Trial Name: NCT03955640 — Phase 1
Breast Cancer Research Study Groups: Treatment (olaparib, hyperthermia)
Breast Cancer Clinical Trial 2023: Hyperthermia Treatment Highlights & Side Effects. Trial Name: NCT03955640 — Phase 1
Hyperthermia Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03955640 — Phase 1

Frequently Asked Questions

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

What adverse effects are associated with Olaparib usage?

"Since this is a Phase 1 trial, there is minimal clinical data backing up the safety and effectiveness of Olaparib - thus it was rated as a 1."

Answered by AI

Are there any recruitment opportunities for this research project presently available?

"Indications from clinicaltrials.gov suggest that this research project is no longer recruiting new participants, having first been published on May 20th 2019 and last updated October 18th 2021. Nonetheless, 5710 other trials are actively seeking contributors at the present moment."

Answered by AI

What medical conditions has Olaparib been found to effectively address?

"Olaparib is the most common treatment for advance directives, but it can also be used to manage malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations with somatic symptoms."

Answered by AI

Am I eligible to join this medical research endeavor?

"This trial seeks to enrol 3 individuals who suffer from hyperthermia and fall within the age range of 18-80. Eligibility necessitates a ECOG performance status between 0-1, regardless of ER/PR/HER2 receptor statuses, and instances of breast cancer recurrence on the chest wall."

Answered by AI

Is this trial a precedent-setting venture?

"Olaparib has been actively researched since the first phase 1 drug trial in 2005, which was supported by AstraZeneca. Today there are 188 ongoing studies for Olaparib across 1469 cities and 60 nations."

Answered by AI

What is the cap for participants in this research project?

"No, enrollment for this study has concluded. The initial listing was posted on May 20th 2019 and the information was last updated October 18 2021. Currently there are 5522 studies related to hyperthermia admitting patients and 188 trials involving Olaparib looking for participants."

Answered by AI

Is there an age cap on the participants of this clinical study?

"This research study seeks participants aged between 18 years and 80 years."

Answered by AI

Are there other research endeavors that have utilized Olaparib?

"Presently, 188 studies are ongoing to explore the efficacy of Olaparib. Of these trials, 27 have advanced to Phase 3. Most research is conducted in Houston, Texas; however there exists a total of 9255 clinical trial sites for this medication around the world."

Answered by AI
~1 spots leftby May 2025