A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:October 2013
End Date:September 2019

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A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and
efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice
in patients who have locally advanced and/or metastatic breast cancer with germline BRCA
mutations.


Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the breast

- Locally advanced breast cancer that is not amenable to curative radiation or surgical
cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy

- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or
BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor

- No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or
metastatic disease (no limit on prior hormonal therapies or targeted anticancer
therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors,
immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against
CTL4 or VEGF)

- Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant,
locally advanced, or metastatic setting unless medically contraindicated

- Have measurable or non-measurable, evaluable disease by the revised response
evaluation criteria in solid tumors (RECIST) v.1.1

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

- First-line locally advanced and/or metastatic breast cancer with no prior adjuvant
chemotherapy unless the Investigator determines that one of the 4 cytotoxic
chemotherapy agents in the control arm would otherwise be offered to the subject

- Prior treatment with a PARP inhibitor (not including iniparib)

- Not a candidate for treatment with at least 1 of the treatments of protocol-specific
physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)

- Subjects who had objective disease progression while receiving platinum chemotherapy
administered for locally advanced or metastatic disease; subjects who received
low-dose platinum therapy administered in combination with radiation therapy are not
excluded

- Subjects who have received platinum in the adjuvant or neoadjuvant setting are
eligible; however, subjects may not have relapsed within 6 months of the last dose of
prior platinum therapy

- Cytotoxic chemotherapy within 14 days before randomization

- Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days
before randomization

- HER2 positive breast cancer

- Active inflammatory breast cancer

- CNS metastases

- Exception: Adequately treated brain metastases documented by baseline CT or MRI
scan that has not progressed since previous scans and that does not require
corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of
CNS symptoms. A repeat CT or MRI following the identification of CNS metastases
(obtained at least 2 weeks after definitive therapy) must document adequately
treated brain metastases.

- Subjects with leptomeningeal carcinomatosis are not permitted

- Prior malignancy except for any of the following:

- Prior BRCA-associated cancer as long as there is no current evidence of the
cancer

- Carcinoma in situ or non-melanoma skin cancer

- A cancer diagnosed and definitively treated ≥ 5 years before randomization with
no subsequent evidence of recurrence

- Known to be human immunodeficiency virus positive

- Known active hepatitis C virus, or known active hepatitis B virus

- Known hypersensitivity to any of the components of talazoparib
We found this trial at
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1150 N 35th Ave # 330
Hollywood, Florida 33021
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24 Sturtevant St
Orlando, Florida 32806
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Albany, New York 12206
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601 East Altamonte Drive
Altamonte Springs, Florida 32701
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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4501 Sand Creek Road
Antioch, California 94509
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515 West Mayfield Road
Arlington, Texas 76014
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Asheville, North Carolina
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Asheville, North Carolina 28801
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Aurora, Colorado 80012
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12605 East 16th Avenue
Aurora, Colorado 80045
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Austin, Texas 78705
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Austin, Texas 78731
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Austin, Texas 78745
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Austin, Texas 78759
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22 South Greene Street
Baltimore, Maryland 21201
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403 South Kings Avenue
Brandon, Florida 33511
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Bronx, New York 10469
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Burnsville, Minnesota 55337
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Cedar Park, Texas 78613
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28207
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Charlotte, North Carolina 28262
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3280 McMullen Booth Road
Clearwater, Florida 33761
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Clifton Park, New York 12065
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Colorado Springs, Colorado 80907
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Concord, New South Wales
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Coon Rapids, Minnesota 55433
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Corinth, Mississippi 38834
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Deerfield Beach, Florida 33442
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Denver, Colorado 80218
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Dickson, Tennessee 37055
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Edina, Minnesota 55435
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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1550 Gateway Boulevard
Fairfield, California 94533
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Flagstaff, Arizona 86002
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Fleming Island, Florida 32003
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Fort Worth, Texas 76177
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Franklin, Tennessee 37067
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Fridley, Minnesota 55432
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Gallatin, Tennessee 37066
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7520 Arroyo Circle
Gilroy, California 95020
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Houston, Texas 77024
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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Houston, Texas 77030
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7651 Medical Drive
Hudson, Florida 34667
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10030 Gilead Road
Huntersville, North Carolina 28078
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46290
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Jacksonville, Florida 32256
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14546 Old Saint Augustine Road
Jacksonville, Florida 32256
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Jacksonville Beach, Florida 32250
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Kansas City, Kansas 66160
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Kansas City, Missouri 64154
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Knoxville, Tennessee 37920
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Lady Lake, Florida 32159
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Lakewood, Colorado 80228
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1301 2nd Avenue Southwest
Largo, Florida 33770
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Lebanon, Tennessee 37087
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521 North Lecanto Highway
Lecanto, Florida 34461
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Lee's Summit, Missouri 64064
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9548 Park Meadows Drive
Lone Tree, Colorado 80124
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