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

Stopped early · Phase 2

Conditions studied: Early Breast Cancer

In brief

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

Key facts

Study ID

NCT03499353

Run by

Pfizer

People needed

61

Starts

2018-08-27

Expected to finish

2020-09-23

Last updated by the study team

2021-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists — Camarillo, California, United States
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• City of Hope Investigational Drug Services (IDS) — Duarte, California, United States
• The Oncology Institute of Hope & Innovation — Glendale, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• The Oncology Institute of Hope & Innovation — Long Beach, California, United States
• UC Irvine Health — Orange, California, United States
• UC Irvine Medical Center — Orange, California, United States
• PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists — Oxnard, California, United States
• Emad Ibrahim, MD, INC. — Redlands, California, United States
• The Oncology Institute of Hope & Innovation — Santa Ana, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Stanford Women's Cancer Center — Stanford, California, United States
• PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists — Ventura, California, United States
• The Oncology Institute of Hope & Innovation — West Covina, California, United States
• The Oncology Institute of Hope & Innovation — Whittier, California, United States
• ICRI — Whittier, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
• Banner Gateway Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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