Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Trial ID or NCT#
NCT03499353
Status
NOT RECRUITING
Purpose
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
Official Title
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
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Wyatt Gross
650-721-4076
View on ClinicalTrials.gov
