← Back to Search

PARP Inhibitor

Talazoparib for Breast Cancer

Phase 2

Recruiting

Led By Neelima Vidula, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Patients with only a VUS (Variant of Unknown Significance), or non-functional BRCA mutation, without a deleterious somatic BRCA 1 or 2 mutation will not be eligible

Triple negative breast cancer with disease progression on at least one prior chemotherapy regimen in the metastatic setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment until treatment discontinuation, up to approximately 2 years

Awards & highlights

Study Summary

This trial is testing if Talazoparib is an effective treatment for metastatic breast cancer in patients with a BRCA 1 or BRCA 2 mutation.

Who is the study for?

This trial is for adults with metastatic breast cancer that has a specific BRCA mutation detected in tumor DNA, not inherited. Participants must have progressed after prior treatments or be unsuitable for them, and should not be on certain drugs or have untreated brain metastases. They need functioning organs and controlled previous cancers, agree to contraception if applicable, and cannot be pregnant.Check my eligibility

What is being tested?

The trial tests Talazoparib's effectiveness against metastatic breast cancer with somatic BRCA mutations. It examines how well patients respond to this PARP inhibitor when they've had limited or no success with other therapies including platinum-based chemotherapy.See study design

What are the potential side effects?

Talazoparib may cause blood cell count changes leading to anemia or infection risk increase, nausea, fatigue, hair loss (alopecia), digestive issues like diarrhea or constipation, headache, coughing and shortness of breath.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer does not have a harmful BRCA 1 or 2 mutation.

Select...

My triple negative breast cancer has worsened after at least one chemotherapy treatment.

Select...

My cancer is hormone receptor positive, HER2 negative, and has worsened despite endocrine therapy.

Select...

I am using birth control, am surgically sterile, or not having heterosexual sex for the study and 7 months after.

Select...

I do not have a BRCA 1 or 2 gene mutation.

Select...

My metastatic breast cancer has BRCA 1 or 2 mutations.

Select...

I am 18 years old or older.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of treatment until treatment discontinuation, up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of treatment until treatment discontinuation, up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment until treatment discontinuation, up to approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Median Progression Free Survival

Secondary outcome measures

Number of Participants with Treatment-related Serious Adverse Events

Objective Response Rate

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

89%

Anemia

78%

Alkaline phosphatase increased

78%

Nausea

78%

White blood cell decreased

67%

Fatigue

67%

Lymphocyte count decreased

56%

Aspartate aminotransferase increased

56%

Hypermagnesemia

56%

Headache

56%

Neutrophil count decreased

56%

Platelet count decreased

56%

Pain in extremity

44%

Constipation

44%

Hypoalbuminemia

44%

Non-cardiac chest pain

44%

Hyponatremia

33%

Creatinine increased

33%

Hypocalcemia

33%

Anorexia

33%

Back pain

33%

Diarrhea

33%

Alanine aminotransferase increased

33%

Alopecia

33%

Blood bilirubin increased

33%

Dizziness

33%

Fever

33%

Hyperglycemia

33%

Pain

33%

Proteinuria

33%

Sinus tachycardia

33%

Vomiting

22%

Hypokalemia

22%

Cough

22%

Abdominal pain

22%

Dyspnea

22%

Hypercalcemia

22%

Hypernatremia

22%

Hypophosphatemia

22%

Hypotension

22%

Hypoxia

22%

Nasal congestion

22%

Neck pain

11%

Weight loss

11%

Periorbital infection

11%

Bone pain

11%

Allergic reaction

11%

Tumor pain

11%

Febrile neutropenia

11%

Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION

11%

Edema limbs

11%

Irregular menstruation

11%

Dysgeusia

11%

Hemoglobin increased

11%

Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT

11%

Skin and subcutaneous tissue disorders - Other, ERYTHEMA

11%

Urinary urgency

11%

Renal and urinary disorders - Other, BLADDER PAIN

11%

Anxiety

11%

Avascular necrosis

11%

Depression

11%

Hypomagnesemia

11%

Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA

11%

Edema face

11%

Hematuria

11%

Lymphocyte count increased

11%

Activated partial thromboplastin time prolonged

11%

Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY

11%

Cystitis noninfective

11%

Epistaxis

11%

Gait disturbance

11%

Gastroesophageal reflux disease

11%

Hypertension

11%

Infections and infestations - Other, SHINGLES ZOSTER

11%

Insomnia

11%

Investigations - Other, BICARBONATE DECREASED

11%

Investigations - Other, BICARBONATE INCREASED

11%

Investigations - Other, BICARBONATE LOW

11%

Metabolism and nutrition disorders - Other, CHLORIDE LEVEL

11%

Mucosal infection

11%

Muscle weakness right-sided

11%

Pericardial effusion

11%

Pleural effusion

11%

Rash acneiform

11%

Respiratory, thoracic and mediastinal disorders - Other, ASTHMA

11%

Skin hyperpigmentation

11%

Skin ulceration

11%

Stomach pain

11%

Thromboembolic event

11%

Tinnitus

11%

Urinary retention

11%

Obesity

100%

80%

60%

40%

20%

Study treatment Arm

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day

400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

Trial Design

1Treatment groups

Experimental Treatment

Group I: TalazoparibExperimental Treatment1 Intervention

-Talazoparib will be provided as capsules for oral administration daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2770

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,471 Total Patients Enrolled

80 Trials studying Breast Cancer

132,882 Patients Enrolled for Breast Cancer

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,910,955 Total Patients Enrolled

110 Trials studying Breast Cancer

36,374 Patients Enrolled for Breast Cancer

Neelima Vidula, MDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital, Massachusetts General Physicians Organization Inc

1 Previous Clinical Trials

84 Total Patients Enrolled

1 Trials studying Breast Cancer

84 Patients Enrolled for Breast Cancer

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03990896 — Phase 2

Breast Cancer Research Study Groups: Talazoparib

Breast Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT03990896 — Phase 2

Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03990896 — Phase 2

Frequently Asked Questions

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

Are there previous case studies of Talazoparib's efficacy?

"City of Hope first researched talazoparib in 2010 and, since then, 23 clinical trials have completed. Currently, there are 60 ongoing studies with many concentrated near Chicago, Illinois."

Answered by AI

In how many different medical institutions is this research being conducted today?

"Some of the hospitals where this trial is enrolling patients include Northwestern University in Chicago, MD Anderson Cancer Center in Houston, and Massachusetts General Hospital Cancer Center which is located in Boston."

Answered by AI

How many people are part of this research project?

"That is correct, a quick glance at the clinicaltrials.gov website will show that this study needs patients and is currently enrolling them. This specific trial was posted on 18th November 2021 with the latest update being 31st October 2022. There are 5 different locations where enrolled patients must attend for treatment and the goal is to have 30 people in total taking part."

Answered by AI

Is Talazoparib a risk to human patients?

"While there is some data supporting Talazoparib's safety, it remains unproven whether the medication is effective. As such, it received a score of 2."

Answered by AI

Are we still looking for more people to participate in this clinical trial?

"Yes, the trial is ongoing and recruiting patients as indicated by information available on clinicaltrials.gov. This particular study was first advertised on 11/18/2021 with the most recent update being 10/31/2022. They are looking to enroll 30 individuals from a pool of 5 eligible locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

Neelima Vidula 2021. "Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03990896.

All > Breast Cancer Boston