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

Last updated on August 24, 2018

FOR MORE INFORMATION
Study Location
PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
Camarillo, California, 93010 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.
Treatment: Up to 24 weeks
Follow up: Estimated 6 weeks
Screening: Up to 4 weeks
Site Visits
Treatment: Up to 9 visits
Follow up: Up to 1 visits
Screening: Up to 2 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

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Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
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 Triple-negative Breast Cancer
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 TRIPLE NEGATIVE BREAST CANCER
TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
THIS IS AN OPEN LABEL SINGLE ARM STUDY

Masking: None (Open Label)
Primary Purpose: Treatment

Early Breast Cancer
Drug: TALAZOPARIB
Talazoparib 1mg/day
Experimental: TALAZOPARIB
SINGLE ARM, NON-RANDOMIZED
Intervention: Drug: TALAZOPARIB
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
122
Same as current
February 25, 2023
October 25, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03499353
C3441020
TALAZOPARIB NEOADJ BC ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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