← Back to Search

PARP Inhibitor

PARP Inhibitor for Triple Negative Breast Cancer

Q: What is the most extensive patient sample size participating in this research?

The trial is currently not recruiting patients - it was initially listed on April 19th 2019 and most recently updated on February 24th 2022. If you are interested in alternative studies, there are 2602 recruitment efforts for <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> participants and 34 trials involving Rucaparib actively seeking enrolment.

Q: Has this kind of medical experiment ever been conducted before?

Rucaparib first entered clinical trials in 2015, led by Clovis <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Inc., and after the success of their initial study with 924 participants it was approved for Phase 2 testing. Presently, there is a wide range of live studies taking place across 831 cities spanning 34 countries to further explore Rucaparib's efficacy.

Q: Is the recruitment process for this trial still open?

Unfortunately, no more candidates are being accepted for this research project. The trial began on April 19th 2019 and was last amended February 24th 2022. If you're looking for other studies related to <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, there are currently 2602 such trials actively recruiting participants in addition to 34 clinical trials seeking people with Rucaparib exposure.

Phase < 1

Waitlist Available

Led By Pavani Chalasani, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Early stage breast cancer (stage I-III) and not be candidate for neoadjuvant chemotherapy

Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

Study Summary

This trial is testing if a Poly(ADP-ribose) polymerase (PARP) inhibitor will make triple negative breast tumors more likely to respond to treatment with a PD-1 checkpoint inhibitor.

Who is the study for?

This trial is for adults over 21 with early stage triple negative breast cancer (TNBC) who haven't had neoadjuvant chemotherapy. Participants must have good bone marrow function, normal kidney and liver tests, and not be pregnant or planning pregnancy. They should also have a performance status of 0-2, indicating they are fully active or at most have some symptoms but don't need bed rest.Check my eligibility

What is being tested?

The study is testing Rucaparib, a PARP inhibitor, to see if it increases PD-L1 expression in TNBC tumors. It's a single-arm trial meaning all participants receive the same treatment without comparison to another drug or placebo.See study design

What are the potential side effects?

Rucaparib may cause side effects like nausea, fatigue, blood count changes increasing infection risk, liver enzyme alterations suggesting liver stress, and potential allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

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

Select...

My breast cancer is in an early stage and I am not a candidate for initial chemotherapy.

Select...

I am able to get out of my bed or chair and move around.

Select...

My blood tests show my bone marrow is working well.

Select...

My breast cancer is triple negative, not responding to hormones or HER2.

Select...

My kidney and liver functions are within the required range.

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of expression of PD-L1 by IHC via core biopsy.

Secondary outcome measures

Measure and quantify change in number of tumor-infiltrating lymphocytes.

Measure cfDNA mutational expression for homologous recombination deficiency (HRD) and correlate with PD-L1 expression at baseline and change overtime.

Measure change in expression of Ki67 by IHC after treatment with PARPi.

+2 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

Nausea

70%

Combined Asthenia/Fatigue

52%

Fatigue

39%

Combined Anaemia and/or decreased hemoglobin

38%

Constipation

38%

Vomiting

37%

Anaemia

35%

Diarrhoea

35%

Alanine aminotransferase increased

34%

Combined ALT/AST increased

33%

Abdominal pain

31%

Dysgeusia

29%

Combined Thrombocytopenia and/or decreased platelets

27%

Aspartate aminotransferase increased

25%

Decreased appetite

23%

Asthenia

22%

Arthralgia

20%

Headache

19%

Combined Neutropenia and/or decreased ANC

19%

Photosensitivity reaction

18%

Cough

17%

Thrombocytopenia

17%

Blood creatinine increased

16%

Dyspepsia

16%

Insomnia

16%

Dizziness

15%

Pruritus

15%

Rash

15%

Dyspnoea

15%

Abdominal pain upper

15%

Back pain

15%

Pyrexia

14%

Platelet count decreased

14%

Neutropenia

13%

Abdominal distension

13%

Upper respiratory tract infection

12%

Hypertension

12%

Oedema peripheral

12%

Hypomagnesaemia

10%

Nasopharyngitis

10%

Alopecia

10%

Taste disorder

10%

Dry skin

10%

Urinary tract infection

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Anxiety

Neutrophil count decreased

Hypercholesterolaemia

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

Incarcerated hernia

General physical health deterioration

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (rucaparib)Experimental Treatment1 Intervention

Patients will be treated with single agent rucaparib for 3wks and then proceed to surgery. Core-biopsies (at the time of diagnosis) and tumor from the surgical resection will be assessed for change in expression of programmed cell death-1 with ligand (PD-L1) by immunohistochemistry (IHC) . Starting Dose 600 mg twice daily Dose Level -1 500 mg twice daily Dose Level -2 400 mg twice daily Dose Level -3 300 mg twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rucaparib

2016

Completed Phase 3

~1990

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,251 Total Patients Enrolled

22 Trials studying Breast Cancer

2,544 Patients Enrolled for Breast Cancer

Pavani Chalasani, MDPrincipal InvestigatorUniversity of Arizona

7 Previous Clinical Trials

918 Total Patients Enrolled

4 Trials studying Breast Cancer

776 Patients Enrolled for Breast Cancer

Media Library

Rucaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03911453 — Phase < 1

Breast Cancer Research Study Groups: Treatment (rucaparib)

Breast Cancer Clinical Trial 2023: Rucaparib Highlights & Side Effects. Trial Name: NCT03911453 — Phase < 1

Rucaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911453 — Phase < 1

Frequently Asked Questions

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

What is the most extensive patient sample size participating in this research?

"The trial is currently not recruiting patients - it was initially listed on April 19th 2019 and most recently updated on February 24th 2022. If you are interested in alternative studies, there are 2602 recruitment efforts for breast cancer participants and 34 trials involving Rucaparib actively seeking enrolment."

Answered by AI

Has this kind of medical experiment ever been conducted before?

"Rucaparib first entered clinical trials in 2015, led by Clovis Oncology Inc., and after the success of their initial study with 924 participants it was approved for Phase 2 testing. Presently, there is a wide range of live studies taking place across 831 cities spanning 34 countries to further explore Rucaparib's efficacy."

Answered by AI

Is the recruitment process for this trial still open?

"Unfortunately, no more candidates are being accepted for this research project. The trial began on April 19th 2019 and was last amended February 24th 2022. If you're looking for other studies related to breast cancer, there are currently 2602 such trials actively recruiting participants in addition to 34 clinical trials seeking people with Rucaparib exposure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors

2019. "Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911453.