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

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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

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.

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
We found this trial at
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499 East Hampden Avenue
Englewood, Colorado 80113
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2500 N State St
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3900 W Avera Drive
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1105 North Central Expressway
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550 Peachtree St NE
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1364 Clifton Rd NE
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Aurora, Colorado 80012
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1515 Holcombe Blvd
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5900 Lake Wright Dr
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300 Halket St.
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