A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:December 13, 2013
End Date:October 31, 2018

Use our guide to learn which trials are right for you!

A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of
talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast
cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to
either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

- Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or

- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic
disease and who have had no prior platinum therapy for metastatic disease


Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the breast

- Locally advanced and/or metastatic disease

- Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation

- Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no
prior platinum for metastatic disease

- ECOG performance status ≤ 1

- Have adequate organ function

Exclusion Criteria:

- Prior enrollment into a clinical trial of a PARP inhibitor

- CNS metastasis except adequately treated brain metastasis documented by baseline CT or
MRI scan that has not progressed since previous scans and that does not require
corticosteroids for management of CNS symptoms

- Prior malignancy except for prior BRCA-associated cancer as long as there is no
current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma
skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study
enrollment with no subsequent evidence of recurrence

- Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus

- Known hypersensitivity to any of the components of talazoparib
We found this trial at
42
sites
2321
mi
from 98109
Lutherville, MD
Click here to add this to my saved trials
1150 N 35th Ave # 330
Hollywood, Florida 33021
2720
mi
from 98109
Hollywood, FL
Click here to add this to my saved trials
2003 Medical Parkway
Annapolis, Maryland 21401
2342
mi
from 98109
Annapolis, MD
Click here to add this to my saved trials
2002 Medical Parkway
Annapolis, Maryland 21401
2342
mi
from 98109
Annapolis, MD
Click here to add this to my saved trials
2001 Medical Parkway
Annapolis, Maryland 21401
2342
mi
from 98109
Annapolis, MD
Click here to add this to my saved trials
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
Deerfield Beach, Florida 33442
2707
mi
from 98109
Deerfield Beach, FL
Click here to add this to my saved trials
Greenbrae, California 94904
Principal Investigator: Peter D. Eisenberg, MD
Phone: 415-925-5040
669
mi
from 98109
Greenbrae, CA
Click here to add this to my saved trials
Hollywood, Florida 33021
2719
mi
from 98109
Hollywood, FL
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Jennifer Litton, MD
Phone: 713-792-2817
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Lida Mina, MD
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
100 North Senate Avenue
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1868
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46290
1862
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
Knoxville, Tennessee 37920
2113
mi
from 98109
Knoxville, TN
Click here to add this to my saved trials
3 Rue Frédéric Combemale
Lille Cedex, 59020
4914
mi
from 98109
Lille Cedex,
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
958
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
959
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
958
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
958
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
1908
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
1971
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
2402
mi
from 98109
New York, NY
Click here to add this to my saved trials
2402
mi
from 98109
New York, NY
Click here to add this to my saved trials
900 Blake Wilbur Drive
Palo Alto, California 94305
704
mi
from 98109
Palo Alto, CA
Click here to add this to my saved trials
2713
mi
from 98109
Pembroke Pines, FL
Click here to add this to my saved trials
2719
mi
from 98109
Pembroke Pines, FL
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
2715
mi
from 98109
Pembroke Pines, FL
Click here to add this to my saved trials
Plantation, Florida 33324
2712
mi
from 98109
Plantation, FL
Click here to add this to my saved trials
974
mi
from 98109
Redondo Beach, CA
Click here to add this to my saved trials
Rockville Centre, New York 11570
2420
mi
from 98109
Rockville Centre, NY
Click here to add this to my saved trials
680
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
962
mi
from 98109
Santa Monica, CA
Click here to add this to my saved trials
961
mi
from 98109
Santa Monica, CA
Click here to add this to my saved trials
Stanford, California 94305
Principal Investigator: Melinda Telli, MD
705
mi
from 98109
Stanford, CA
Click here to add this to my saved trials
Stanford, California 94305
704
mi
from 98109
Stanford, CA
Click here to add this to my saved trials