Home
Clinical Trials
NCT03499353

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2020-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neoadjuvant Therapy, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE Breast Cancer, BRCA Positive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

THIS IS AN OPEN LABEL SINGLE ARM STUDY

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TALAZOPARIB

SINGLE ARM, NON-RANDOMIZED

Group Type EXPERIMENTAL

TALAZOPARIB

Intervention Type DRUG

Talazoparib 1mg/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TALAZOPARIB

Talazoparib 1mg/day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Germline BRCA 1/2 Mutation Positive
* Women and men at least 18 years of age or older.
* Histologically confirmed invasive adenocarcinoma of the breast
* HER2 negative breast cancer as defined by ASCO-CAP criteria
* Tumor greater than or equal toT1, N0-3
* No evidence of distant metastasis
* Adequate bone marrow, hepatic, and renal function
* ECOG performance status 0 or 1

Exclusion Criteria

* Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
* Evidence of distant metastasis apparent prior to randomization
* Patients with inflammatory breast carcinoma
* Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
* Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
* Prior treatment with a PARP inhibitor in any disease setting
* Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
* Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol
* Major surgery within 14 days prior to study entry
* Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
* Active clinically significant infection
* Clinically significant bleeding diathesis or coagulopathy
* Non healing wound, ulcer or bone fracture
* Known hypersensitivity to any of the components of talazoparib
* Patients with myelodysplastic syndrome/acute myeloid leukemia
* Patients with uncontrolled seizures.
* Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banner Gateway Medical Center

Gilbert, Arizona, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists

Camarillo, California, United States

Site Status

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

Site Status

City of Hope Investigational Drug Services (IDS)

Duarte, California, United States

Site Status

The Oncology Institute of Hope & Innovation

Glendale, California, United States

Site Status

Glendale Adventist Medical Center

Glendale, California, United States

Site Status

The Oncology Institute of Hope & Innovation

Long Beach, California, United States

Site Status

UC Irvine Health

Orange, California, United States

Site Status

UC Irvine Medical Center

Orange, California, United States

Site Status

PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Site Status

Emad Ibrahim, MD, INC.

Redlands, California, United States

Site Status

The Oncology Institute of Hope & Innovation

Santa Ana, California, United States

Site Status

Stanford Cancer Institute

Stanford, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Stanford Women's Cancer Center

Stanford, California, United States

Site Status

PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists

Ventura, California, United States

Site Status

The Oncology Institute of Hope & Innovation

West Covina, California, United States

Site Status

The Oncology Institute of Hope & Innovation

Whittier, California, United States

Site Status

ICRI

Whittier, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Englewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Parker, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Thornton, Colorado, United States

Site Status