You are here

Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer

Last updated on April 18, 2019

FOR MORE INFORMATION
Study Location
Texas Oncology-Denton South
Denton, Texas, 76210 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Early Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Germline BRCA 1/2 Mutation Positive

- Women and men at least 18 years of age or older.

- Histologically confirmed invasive triple negative Breast Cancer

- Tumor >1.5 cm.

- No evidence of distant metastasis

-

  Adequate bone marrow, hepatic, and renal function

- ECOG performance status 0 or 1


Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any previous antitumor therapies for the current cancer event

- Evidence of distant metastasis apparent prior to randomization

- Patients with inflammatory breast carcinoma

- Malignancy within the last 3 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 P gp inhibitors or inducers or BCRP inhibitors

- Patients who are unwilling or unable to use 2 highly effective methods of
contraception as outlined in this protocol

- Major surgery within 14 days prior to study entry

- No known history of cardiovascular disease

- 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

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 6 weeks
Screening: Up to 4 weeks
Treatment: Up to 24 weeks
Site Visits
Follow up: Up to 1 visits
Screening: Up to 2 visits
Treatment: Up to 9 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Ultrasound
Questionnaire
Keeping a diary
Mri
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Other
Blood test
Vital signs and measurements
NCT03499353
Pfizer
Recruiting
Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now