Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Condition: Early Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: TALAZOPARIB
Intervention description: Talazoparib 1mg/day
Intervention MeSH terms: Talazoparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: THIS IS AN OPEN LABEL SINGLE ARM STUDY
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoadjuvant Therapy, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE Breast Cancer, BRCA Positive

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
    

Eligibility criteria:

        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