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Olaparib for Breast Cancer

M D Anderson Cancer Center, Houston, TX
Breast Cancer+14 More ConditionsOlaparib - Drug
Eligibility
18+
Female

Study Summary

This trial studies olaparib with cediranib or AZD6738 as a treatment for patients with BRCA mutated breast cancer that has spread to other places in the body.

Eligible Conditions
  • Stage III Breast Cancer
  • BRCA2 Gene Mutation
  • BRCA1 Gene Mutation
  • Stage IIIB Breast Cancer
  • Metastatic Breast Cancer
  • Stage IV Breast Cancer
  • HER2/Neu Negative Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 30 days post treatment

Day 30
Biomarker analysis
Duration of response (DOR)
Heart rate
Progression free survival (PFS)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Side Effects for

gBRCAm
56%Nausea
44%Fatigue
44%Anaemia
28%Vomiting
17%Diarrhoea
16%Dyspepsia
15%Dizziness
15%Asthenia
14%Neutropenia
13%Headache
13%Arthralgia
13%Abdominal pain
11%Decreased appetite
10%Nasopharyngitis
10%Abdominal pain upper
10%Cough
10%Dyspnoea
9%Dysgeusia
9%Blood creatinine increased
8%Back pain
8%Alanine aminotransferase increased
8%Insomnia
8%Influenza like illness
8%Influenza
8%Alopecia
7%Pyrexia
7%Abdominal distension
7%Hypomagnesaemia
7%Leukopenia
6%Thrombocytopenia
6%Constipation
6%Peripheral swelling
6%Urinary tract infection
6%Bronchitis
6%Neutrophil count decreased
6%Platelet count decreased
6%White blood cell count decreased
5%Pain in extremity
5%Depression
5%Myalgia
5%Anxiety
5%Musculoskeletal pain
5%Pruritus
3%Gastrooesophageal reflux disease
3%Rash
3%Pulmonary embolism
3%Hypertension
3%Abdominal pain lower
3%Oropharyngeal pain
2%Vitamin d deficiency
2%Glomerular filtration rate decreased
2%Acute myeloid leukaemia
2%Upper respiratory tract infection
1%Glaucoma
1%Sudden death
1%Drug hypersensitivity
1%Mesenteric vein thrombosis
1%Non-hodgkin's lymphoma
1%Angina unstable
1%Deep vein thrombosis
1%Oral candidiasis
1%Subileus
1%Abdominal hernia
1%Sepsis
1%Haemorrhoids
1%Mucosal inflammation
1%Lower respiratory tract infection
1%Procedural pain
1%Burkitt's lymphoma
1%Papillary thyroid cancer
1%Transient ischaemic attack
1%Myelodysplastic syndrome
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the gBRCAm ARM group. Side effects include: Nausea with 56%, Fatigue with 44%, Anaemia with 44%, Vomiting with 28%, Diarrhoea with 17%.

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm II (olaparib plus ceralasertib)
1 of 2
Arm I (olaparib plus cediranib)
1 of 2

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Arm II (olaparib plus ceralasertib)Experimental Group · 2 Interventions: Ceralasertib, Olaparib · Intervention Types: Drug, Drug
Arm I (olaparib plus cediranib)Experimental Group · 2 Interventions: Cediranib, Olaparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
Not yet FDA approved
Cediranib
Not yet FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days post treatment

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,464 Total Patients Enrolled
146 Trials studying Breast Cancer
31,736 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,282 Previous Clinical Trials
41,235,293 Total Patients Enrolled
932 Trials studying Breast Cancer
1,541,944 Patients Enrolled for Breast Cancer
Banu ArunPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
656 Total Patients Enrolled
1 Trials studying Breast Cancer
66 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 16 more weeks.
You have received treatment with a specific medication called PARP inhibitor for at least 4 months before your disease worsened.
References

Frequently Asked Questions

Are more participants needed for this experiment at the present time?

"Indeed, clinicaltrials.gov reveals that this medical experiment is actively accepting participants. It was initially posted on July 28th 2020 and updated as recently as March 31st 2022. Approximately 60 individuals are expected to be recruited from a single site." - Anonymous Online Contributor

Unverified Answer

What is the current capacity for enrolment in this research project?

"Indeed, the clinical trial data present on clinicialtrials.gov confirms that recruitment for this study is still ongoing. It was initially posted on July 28th 2020 and most recently updated in March 31st 2022, with a need to recruit 60 patients from 1 medical centre." - Anonymous Online Contributor

Unverified Answer

To what degree can Olaparib be considered a risk to human health?

"As this is a second-phase trial, there's evidence of Olaparib's safety making its score 2 out of 3. However, no data exists to support the drug's efficacy yet." - Anonymous Online Contributor

Unverified Answer

Could you elaborate on any additional research done with Olaparib?

"Olaparib is the subject of 204 active research trials, 27 which are in their final phase. While Houston, Texas houses many studies for this drug, there are over 9 thousand other locations running clinical trials on its efficacy." - Anonymous Online Contributor

Unverified Answer

Is this experiment the inaugural endeavor of its kind?

"Globally, there are 204 dynamic clinical trials involving the drug Olaparib being conducted across 59 countries and 1490 cities. The original trial for this medication began in 2005 when 98 participants took part in a Phase 1 Drug Approval study sponsored by AstraZeneca. Since then, 113 studies have been concluded." - Anonymous Online Contributor

Unverified Answer

What ailments is Olaparib typically prescribed to treat?

"Olaparib is a medication that can be prescribed to treat numerous conditions, ranging from advanced directives to malignant neoplasm of ovary and primary peritoneal cancer. It may also be administered for hallucinations and somatic problems." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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