Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | August 27, 2018 |
End Date: | December 1, 2023 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
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 TRIPLE-NEGATIVE BREAST CANCER
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 TRIPLE NEGATIVE BREAST
CANCER
NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST
CANCER
TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS
WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED
BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED
BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
Inclusion Criteria:
- Germline BRCA 1/2 Mutation Positive
- Women and men at least 18 years of age or older.
- Histologically confirmed invasive triple negative Breast Cancer
- Tumor greater than or equal toT1
- 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:: 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 2 highly effective methods 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
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