← Back to Search

PARP Inhibitor

Talazoparib Tosylate for Breast Cancer

Phase 2

Waitlist Available

Led By Melinda L Telli, MD

Research Sponsored by Melinda Telli

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 1 year

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it works well against advanced breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response (OR)

Secondary outcome measures

Clinical Benefit (CB)

Progression-free Survival (PFS)

Side effects data

From 2022 Phase 2 trial • 21 Patients • NCT02401347

45%

Fatigue

45%

Nausea

35%

Platelet count decreased

35%

Constipation

25%

Alkaline phosphatase increased

25%

Neutropenia

25%

Anorexia

25%

Back pain

20%

Anemia

15%

Vomiting

15%

Thrombocytopenia

15%

Aspartate Amino Transferase increased

15%

Alanine aminotransferase increased

15%

Pain in extremity

15%

Pain

15%

Dyspnea

15%

Cough

15%

Alopecia

10%

Shoulder Pain

10%

Headache

10%

Hyponatremia

10%

Abdominal pain

10%

Diarrhea

10%

Fever

10%

Myalgia

Flu-like symptoms

Stomach pain

Mucositis oral

Bloating

Lymphedema

Trismus

Peripheral sensory neuropathy

Allergic rhinitis

Weakness in extremities, right side

Heartburn

Facial muscle weakness

Intracranial masses, supratentorial and infratentoria

Hypocalcemia

Bone pain

Pneumothorax, post-lung biopsy

Edema limbs (peripheral edema)

Weight loss

Deep venous thrombosis

Weakness in extremity, right leg, progressing

Anxiety

Epistaxis

Sore throat

Rash, maculo-papular

Thromboembolic event

100%

80%

60%

40%

20%

Study treatment Arm

Cohort B - HER2-negative Solid Tumor

Cohort A - Triple-negative Breast Cancer

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B - HER2-negative solid tumorExperimental Treatment1 Intervention

Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily.

Group II: Cohort A - Triple-negative Breast CancerExperimental Treatment1 Intervention

Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Melinda TelliLead Sponsor

1 Previous Clinical Trials

41 Total Patients Enrolled

1 Trials studying Breast Cancer

41 Patients Enrolled for Breast Cancer

BioMarin PharmaceuticalIndustry Sponsor

157 Previous Clinical Trials

189,990 Total Patients Enrolled

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,916,005 Total Patients Enrolled

112 Trials studying Breast Cancer

36,444 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

How can interested parties sign up for this experiment?

"The listing on clinicaltrials.gov says that this study is admitting new patients. According to the site, the trial was first posted on 8/1/2015 and edited on 9/1/2021. Right now, the study is looking for 40 participants at 1 location."

Answered by AI

How many people are participating in this clinical research?

"That is correct. The website provides information that this study, which was first posted on 8/1/2015, and updated last on 9/1/2021, is still recruiting patients. There is a need for 40 more participants at 1 site."

Answered by AI

Has Talazoparib Tosylate received FDA approval?

"Talazoparib Tosylate has received a safety score of 2. Although there is some evidence to support its safety, Phase 2 trials have not yet demonstrated efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors

Melinda Telli 2015. "Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02401347.