Research & Innovation

Breast Clinical Trials

Clinical Trials

Pfizer C3441020

A Phase 2, Non-Randomized, Open Label, Single Arm, Multi-Center Study of Talazoparib for Neoadjuvant Treatment of Germline BRCA 1/2 Mutation Patients with Early Triple- Negative Breast Cancer

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936
Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Talazoparib

Synopsis: You are being asked to take part in this study because you have early stage triple‑negative breast cancer and may be a carrier of a BRCA gene mutation. The purpose of this study is to determine if the study drug talazoparib (also called BMN 673) is safe when given as a breast cancer treatment and to evaluate how your cancer responds. Talazoparib is given in a capsule and is taken by mouth at approximately the same time every day.

Before you enter this study, you may be asked to provide a blood sample to see if you have a certain mutation in genes known as BRCA. If the results confirm that your BRCA1 or BRCA2 gene is mutated you may be provided with some additional cancer risk information (this information has not been reviewed or approved by Food and Drug Administration [FDA] and does not form part of the research study.  If you have already had a BRCA test, your doctor will review the test results to determine if these results may be used or if another sample will be taken.

  

 

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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 greater than or equal toT1
  • No evidence of distant metastasis
  • Adequate bone marrow, hepatic, and renal function
  • ECOG performance status 0 or 1

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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:: 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 2 highly effective methods 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

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