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Pfizer C3441020: A phase II, 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

Description

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 cancer responds to it.

Status

Accepting new patients

Primary Study Objective(s)

The study objective is to evaluate the pathological complete response to talazoparib after completion of 24 weeks of neoadjuvant therapy followed by surgery.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have germline BRCA 1/2 mutation positive
  • Are women or men at least 18 years old or older
  • Have histologically confirmed, invasive triple-negative breast cancer
  • Have a tumor larger than 1.5 centimeters
  • Have no evidence of distant metastasis
  • Have adequate bone marrow, hepatic and renal function
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1

Excluding patients who:

  • Have had any previous anti-tumor therapies for the current cancer event
  • Have evidence of distant metastasis apparent prior to randomization
  • Have inflammatory breast carcinoma
  • Have had malignancy within the past three years
  • Have had previous or concomitant systemic anti-cancer therapies used for the treatment of cancer in the past three years
  • Have had prior treatment with a PARP inhibitor in any disease setting
  • Have had concomitant use of PARP inhibitors or inducers or BCRP inhibitors
  • Are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol
  • Have had major surgery within 14 days prior to study entry
  • Have had no known history of cardiovascular disease
  • Have an active, clinically significant infection
  • Have clinically significant bleeding diathesis or coagulopathy
  • Have a non-healing wound, ulcer or bone fracture
  • Have a known hypersensitivity to any of the components of talazoparib
  • Have myelodysplastic syndrome or acute myeloid leukemia
  • Have uncontrolled seizures
  • Have evidence of other disease or concomitant medical or psychiatric problems, which, in the opinion of the investigator, would prevent completion of treatment

Learn more about breast cancer

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Sramila Aithal

Damien Hansra