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

NCT03499353

Last updated date
Study Location
OC Blood and Cancer Care
Laguna Hills, California, 92653, United States
Contact
1-800-718-1021

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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

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Female
18 Years+
years
MULTIPLE SITES
Early Breast CancerTalazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
NCT03499353
  1. Laguna Hills, California
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  17. Orange, California
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  19. Redlands, California
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  25. Whittier, California
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  27. Aurora, Colorado
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  29. Colorado Springs, Colorado
  30. Denver, Colorado
  31. Denver, Colorado
  32. Englewood, Colorado
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  34. Littleton, Colorado
  35. Lone Tree, Colorado
  36. Longmont, Colorado
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  38. Pueblo, Colorado
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  44. Jacksonville, Florida
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  81. Tualatin, Oregon
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  100. Washington, Pennsylvania
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  106. Knoxville, Tennessee
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ALL GENDERS
18 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Official Title  ICMJE 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
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Early Breast Cancer
Intervention  ICMJE Drug: TALAZOPARIB
Talazoparib 1mg/day
Study Arms  ICMJE Experimental: TALAZOPARIB
SINGLE ARM, NON-RANDOMIZED
Intervention: Drug: TALAZOPARIB
Publications * Litton JK, Scoggins ME, Hess KR, Adrada BE, Murthy RK, Damodaran S, DeSnyder SM, Brewster AM, Barcenas CH, Valero V, Whitman GJ, Schwartz-Gomez J, Mittendorf EA, Thompson AM, Helgason T, Ibrahim N, Piwnica-Worms H, Moulder SL, Arun BK. Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant. J Clin Oncol. 2020 Feb 10;38(5):388-394. doi: 10.1200/JCO.19.01304. Epub 2019 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 23, 2020)
61
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
122
Actual Study Completion Date  ICMJE September 23, 2020
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499353
Other Study ID Numbers  ICMJE C3441020
TALAZOPARIB NEOADJ BC ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP