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

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Early Breast Cancer

Treatments

Drug: TALAZOPARIB

Study type

Interventional

Funder types

Industry

Identifiers

NCT03499353

TALAZOPARIB NEOADJ BC (Other Identifier)

C3441020

Details and patient eligibility

About

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

Full description

TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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