Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

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

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

What this study is about

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

What this study is about