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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01945775




Registration number
NCT01945775
Ethics application status
Date submitted
11/09/2013
Date registered
19/09/2013
Date last updated
20/01/2022

Titles & IDs
Public title
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Scientific title
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
Secondary ID [1] 0 0
C3441009
Secondary ID [2] 0 0
673-301
Universal Trial Number (UTN)
Trial acronym
EMBRACA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
BRCA 1 Gene Mutation 0 0
BRCA 2 Gene Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - talazoparib
Treatment: Drugs - Physician's-Choice

Experimental: talazoparib - Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days

Active Comparator: Physician's-Choice - Capecitabine, Eribulin, Gemcitabine or Vinorelbine


Treatment: Drugs: talazoparib
Until progression or unacceptable toxicity develops

Treatment: Drugs: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
Timepoint [1] 0 0
Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response: Investigator Assessment
Timepoint [1] 0 0
Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
Secondary outcome [3] 0 0
Trough Plasma Talazoparib Concentrations
Timepoint [3] 0 0
Predose on Day 1 of Cycle 2, 3 and 4
Secondary outcome [4] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [5] 0 0
Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology
Timepoint [5] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
Secondary outcome [6] 0 0
Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry
Timepoint [6] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [7] 0 0
Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs
Timepoint [7] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [8] 0 0
Number of Participants Taking At-least One Concomitant Medication
Timepoint [8] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2021
Sample size
Target
Accrual to date
Final
431
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton - Milton
Recruitment hospital [3] 0 0
Icon Cancer Care, Corporate Office - South Brisbane
Recruitment hospital [4] 0 0
ICON Cancer Care - South Brisbane
Recruitment hospital [5] 0 0
ICON Cancer Foundation - South Brisbane
Recruitment hospital [6] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [7] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [11] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [12] 0 0
Cancer Care SA PTY Ltd - Kurralta Park
Recruitment hospital [13] 0 0
Cancer Care SA trading as Icon Pharmacy Adelaide - Kurralta Park
Recruitment hospital [14] 0 0
Victoria Breast and Oncology Care - East Melbourne
Recruitment hospital [15] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [16] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [17] 0 0
Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only) - Heidelberg West
Recruitment hospital [18] 0 0
Austin Health, The Austin Hospital - Melbourne
Recruitment hospital [19] 0 0
Slade Pharmacy Mount Waverley - Mount Waverley
Recruitment hospital [20] 0 0
Nova Pharmacy - Wendouree
Recruitment hospital [21] 0 0
Ballarat Oncology & Haematology Services Clinical Trials Unit - Wendouree
Recruitment hospital [22] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [23] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [24] 0 0
Sir Charles Gairdner Hospital Lung Institute Of Western Australia - Nedlands
Recruitment hospital [25] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [26] 0 0
Icon Cancer Care - Milton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4104 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [12] 0 0
3084 - Melbourne
Recruitment postcode(s) [13] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [14] 0 0
3353 - Wendouree
Recruitment postcode(s) [15] 0 0
3355 - Wendouree
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment postcode(s) [18] 0 0
4066 - Auchenflower
Recruitment postcode(s) [19] 0 0
4066 - Milton
Recruitment outside Australia
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California
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Connecticut
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Indiana
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Kansas
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New York
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North Carolina
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Avila
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Barcelona
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Sumy
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Leeds
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medivation, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01945775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries