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

NCT01945775

Last updated date
Study Location
Arizona Oncology Associates P.C. - NAHOA
Flagstaff, Arizona, 86001, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene MutationA Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) NCT01945775
  1. Flagstaff, Arizona
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene MutationA 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) NCT02034916
  1. Greenbrae, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Palo Alto, California
  6. Porter Ranch, California
  7. Redondo Beach, California
  8. San Francisco, California
  9. Santa Monica, California
  10. Stanford, California
  11. Stanford, California
  12. Deerfield Beach, Florida
  13. Hollywood, Florida
  14. Hollywood, Florida
  15. Miami, Florida
  16. Pembroke Pines, Florida
  17. Pembroke Pines, Florida
  18. Pembroke Pines, Florida
  19. Plantation, Florida
  20. Indianapolis, Indiana
  21. Indianapolis, Indiana
  22. Indianapolis, Indiana
  23. Indianapolis, Indiana
  24. Indianapolis, Indiana
  25. Indianapolis, Indiana
  26. Annapolis, Maryland
  27. Annapolis, Maryland
  28. Annapolis, Maryland
  29. Baltimore, Maryland
  30. Lutherville, Maryland
  31. New York, New York
  32. New York, New York
  33. Rockville Centre, New York
  34. Knoxville, Tennessee
  35. Nashville, Tennessee
  36. Nashville, Tennessee
  37. Houston, Texas
  38. Lille Cédex,
  39. Lyon Cedex 08,
  40. Marseille,
  41. Nantes BP 20215,
  42. Strasbourg,
  43. Toulouse,
  44. Tours Cedex 9,
  45. Erlangen, Bavaria
  46. Muenchen, Bavaria
  47. Muenchen, Bavaria
  48. Munich, Bavaria
  49. Trier, Rheinland-pfalz
  50. Dresden, Saxony
  51. Berlin,
  52. Duesseldorf,
  53. Essen,
  54. Kiel,
  55. Stralsund,
  56. Tuebingen,
  57. A Coruna,
  58. Barcelona,
  59. Jaen,
  60. Madrid,
  61. Madrid,
  62. Madrid,
  63. San Juan de Alicante,
  64. Sevilla,
  65. Zaragoza,
  66. Cambridge, England
  67. London, England
  68. Preston, Lancashire
  69. London,
  70. Manchester,
  71. Sutton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
Intervention  ICMJE
  • Drug: talazoparib
    Until progression or unacceptable toxicity develops
  • Drug: Physician's-Choice
    Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Study Arms  ICMJE
  • Experimental: talazoparib
    Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
    Intervention: Drug: talazoparib
  • Active Comparator: Physician's-Choice
    Capecitabine, Eribulin, Gemcitabine or Vinorelbine
    Intervention: Drug: Physician's-Choice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
431
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2013)
429
Estimated Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   France,   Germany,   Ireland,   Israel,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945775
Other Study ID Numbers  ICMJE 673-301
C3441009 ( Other Identifier: Alias Study Number )
2013-002716-28 ( EudraCT Number )
U1111-1155-7579 ( Other Identifier: Universal Trial Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP