Trial Search Results

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

This study is looking at the PARPi Talazoparib in the neoadjuvant setting for patients with germline BRCA mutation and early TNBC. Treatment is 24 weeks (6 months) of talazoparib prior to surgery, evaluated routinely via US to monitor tumor response.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Stanford Investigator(s):

Intervention(s):

  • Drug: TALAZOPARIB

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Wyatt Gross
650-721-4076
Not Recruiting