Back to resultsA 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) (ABRAZO)
Primary Purpose
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
talazoparib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast cancer, BRCA mutation, PARP inhibitor, BRCA 1, BRCA 2
Eligibility Criteria
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
Sites / Locations
- Marin Cancer Care, Inc.
- UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD
- UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
- TRIO-US Central Administration
- Stanford Women's Cancer Center
- UCLA Hematology Oncology- Porter Ranch
- Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
- University of California, San Francisco: Helen Diller Comprehensive Cancer Center
- UCLA Hematology-Oncology
- Stanford Cancer Institute
- Stanford Hospital and Clinics
- Sylvester at Deerfield Beach
- Memorial Cancer Institute at Memorial Regional Hospital
- Memorial Regional Hospital
- University of Miami Hospital & Clinics
- Memorial Breast Cancer Center at Memorial Hospital West
- Memorial Cancer Institute at Memorial Hospital West
- Memorial Hospital West
- Sylvester at Plantation
- ICRC
- Indiana University Health Melvin and Bren Simon Cancer Center
- Investigational Drug Services
- IU Health University Hospital
- Sidney & Lois Eskenazi Hospital
- Springmill Medical Clinic
- Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology
- Anne Arundel Medical Center (AAMC), Research Pharmacy
- Anne Arundel Medical Center (AAMC)
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
- Memorial Sloan Kettering Evelyn H. Lauder Breast Center
- Memorial Sloan-Kettering Cancer Center
- Memorial Sloan Kettering Rockville Centre
- University of Tennessee Medical Center
- Tennessee Oncology, PLLC
- The Sarah Cannon Research Institute
- The University of Texas MD Anderson Cancer Center
- Centre Oscar Lambret
- Centre Leon Berard
- Institut Paoli Calmettes
- Hopital Prive du Confluent
- Hopitaux Universitaires de Strasbourg - Hopital Civil
- Institut Universitaire du Cancer Toulouse - Oncopole
- CHU Bretonneau Centre Henry Kaplan
- Universitaetsklinikum Erlangen
- IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum
- Klinikum rechts der Isar der TU Muenchen
- University of Munich (LMU) Grosshadern Hospital
- Klinikum Mutterhaus Der Borromaeerinnen Ggmbh
- University Hospital Carl Gustav Carus
- Helios Klinikum Berlin-Buch
- University Hospital Duesseldorf
- Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie
- Universitaetsklinikum Schleswig-Holstein
- g.SUND Gynaekologie Kompetenzzentrum Stralsund
- Universitaets-Frauenklinik
- Complejo Hospitalario Universitario A Coruna
- Hospital Universitari Vall d'Hebron
- Complejo Hospitalario de Jaen
- Hospital General Universitario Gregorio Maranon
- MD Anderson Cancer Center International Espana
- Hospital Clinico San Carlos
- Hospital Universitario San Juan de Alicante
- Hospital Universitario Virgen Macarena
- Hospital Universitario Miguel Servet
- Cambridge University Hospital NHS Foundation Trust
- Sarah Cannon Research Institute UK
- Lancashire Teaching Hospitals NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
- The Christie NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
talazoparib
Arm Description
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 Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).
Secondary Outcome Measures
Clinical Benefit Rate-24 (CBR-24)
CBR24: Percentage of participants with a best response of CR, PR or stable disease (SD) sustained for at least 24 weeks, as assessed by IRF using RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions.
Duration of Response (DOR)
DOR: Time from first documentation of CR or PR, to PD by IRF assessment using RECIST 1.1, or to death due to any cause, whichever occurred first. CR: Disappearance of all non-nodal target and non-target lesions, with target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PD or death at the analysis date were censored at last tumor assessment date prior to on or before initiation of a new anticancer therapy or before the data cutoff date.
Progression Free Survival (PFS)
PFS was defined as the time in months from the first dose of study drug to the first documentation of PD by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PFS event at the analysis were censored at last tumor assessment date prior to data cutoff or date of new anticancer treatment initiation, whichever occurred first.
Overall Survival (OS)
OS was defined as the time from first dose of study drug to death due to any cause. For participants without a death date at the time of data cutoff or permanently lost to follow-up, OS was right-censored at the date the participant was last known to be alive on or before the data cutoff date.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment-related SAE was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. Related TEAEs are TEAEs that were judged by the investigators as possibly, probably, or definitely related to study drug. AEs included both SAES and non SAES.
Number of Participants With Outcome in Response to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Hematology Parameter)
Laboratory tests included hematology (hemoglobin [low], leucocytes [low], lymphocytes [low], neutrophils [low], platelets [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for hematology laboratory parameter is reported in this outcome measure.
Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Chemistry Parameter)
Laboratory tests included serum chemistry (alanine aminotransferase [high], albumin [low], alkaline phosphatase [high], aspartate aminotransferase [high], bilirubin [high], calcium [low], glucose [high], magnesium [low], phosphate [low], potassium [high], potassium [low], sodium [high], sodium [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for chemistry laboratory parameter is reported in this outcome measure.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Criteria for clinically significant vital signs changes: 1) Blood pressure: systolic blood pressure (SBP): greater than or equal to (>=30) millimeters of mercury (mmHg) increase from baseline, diastolic blood pressure (DBP): >=20 mmHg decrease from baseline; 2) Heart rate (HR): absolute HR greater than (>) 120 beats per minute (bpm) and >30 bpm increase from baseline, absolute HR less than (<) 50 bpm and >20 bpm decrease from baseline; 3) Weight: >10% decrease from baseline. Number of participants with any clinically significant change from baseline for blood pressure, heart rate and weight are reported in this outcome measure.
Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of Participants With At Least 1 Concomitant Medication
Number of participants taking any non-study medications, therapies, including herbal supplements during the treatment-emergent period for the management of an adverse event or for the treatment of any other disease.
Trough Concentration Versus Time Summary of Talazoparib
Concentrations below the limit of quantitation values less than or equal to (<=) 25 picogram per milliliter (pg/mL) were set as zero. Pharmacokinetic (PK) analysis was not done separately for each reporting arm and cohorts were combined for PK analysis.
Full Information
NCT ID
NCT02034916
First Posted
January 9, 2014
Last Updated
October 10, 2019
Sponsor
Pfizer
Collaborators
Myriad Genetic Laboratories, Inc., Medivation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02034916
Brief Title
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)
Acronym
ABRAZO
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Primary Analysis and study completed. Not stopped due to safety concerns.
Study Start Date
December 13, 2013 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Myriad Genetic Laboratories, Inc., Medivation, Inc.
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Keywords
Breast cancer, BRCA mutation, PARP inhibitor, BRCA 1, BRCA 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
talazoparib
Arm Type
Experimental
Arm Description
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
Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
Intervention Type
Drug
Intervention Name(s)
talazoparib
Other Intervention Name(s)
MDV3800, BMN673
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).
Time Frame
From randomization until data cutoff date (01 Sep 2016)
Secondary Outcome Measure Information:
Title
Clinical Benefit Rate-24 (CBR-24)
Description
CBR24: Percentage of participants with a best response of CR, PR or stable disease (SD) sustained for at least 24 weeks, as assessed by IRF using RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions.
Time Frame
From randomization until data cutoff date (01 Sep 2016)
Title
Duration of Response (DOR)
Description
DOR: Time from first documentation of CR or PR, to PD by IRF assessment using RECIST 1.1, or to death due to any cause, whichever occurred first. CR: Disappearance of all non-nodal target and non-target lesions, with target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PD or death at the analysis date were censored at last tumor assessment date prior to on or before initiation of a new anticancer therapy or before the data cutoff date.
Time Frame
From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])
Title
Progression Free Survival (PFS)
Description
PFS was defined as the time in months from the first dose of study drug to the first documentation of PD by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PFS event at the analysis were censored at last tumor assessment date prior to data cutoff or date of new anticancer treatment initiation, whichever occurred first.
Time Frame
From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])
Title
Overall Survival (OS)
Description
OS was defined as the time from first dose of study drug to death due to any cause. For participants without a death date at the time of data cutoff or permanently lost to follow-up, OS was right-censored at the date the participant was last known to be alive on or before the data cutoff date.
Time Frame
From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016])
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment-related SAE was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. Related TEAEs are TEAEs that were judged by the investigators as possibly, probably, or definitely related to study drug. AEs included both SAES and non SAES.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With Outcome in Response to Adverse Events (AEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Hematology Parameter)
Description
Laboratory tests included hematology (hemoglobin [low], leucocytes [low], lymphocytes [low], neutrophils [low], platelets [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for hematology laboratory parameter is reported in this outcome measure.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Chemistry Parameter)
Description
Laboratory tests included serum chemistry (alanine aminotransferase [high], albumin [low], alkaline phosphatase [high], aspartate aminotransferase [high], bilirubin [high], calcium [low], glucose [high], magnesium [low], phosphate [low], potassium [high], potassium [low], sodium [high], sodium [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for chemistry laboratory parameter is reported in this outcome measure.
Time Frame
Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description
Criteria for clinically significant vital signs changes: 1) Blood pressure: systolic blood pressure (SBP): greater than or equal to (>=30) millimeters of mercury (mmHg) increase from baseline, diastolic blood pressure (DBP): >=20 mmHg decrease from baseline; 2) Heart rate (HR): absolute HR greater than (>) 120 beats per minute (bpm) and >30 bpm increase from baseline, absolute HR less than (<) 50 bpm and >20 bpm decrease from baseline; 3) Weight: >10% decrease from baseline. Number of participants with any clinically significant change from baseline for blood pressure, heart rate and weight are reported in this outcome measure.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Description
Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Number of Participants With At Least 1 Concomitant Medication
Description
Number of participants taking any non-study medications, therapies, including herbal supplements during the treatment-emergent period for the management of an adverse event or for the treatment of any other disease.
Time Frame
Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)
Title
Trough Concentration Versus Time Summary of Talazoparib
Description
Concentrations below the limit of quantitation values less than or equal to (<=) 25 picogram per milliliter (pg/mL) were set as zero. Pharmacokinetic (PK) analysis was not done separately for each reporting arm and cohorts were combined for PK analysis.
Time Frame
Predose on Day 1 of Cycle 1, 2, 3, and 4 (data cutoff date: 01 Sep 2016)
Other Pre-specified Outcome Measures:
Title
Time to Deterioration in Global Health Status/Quality of Life (QOL) and Functional Status as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Description
Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the functional status score and global health status/QOL score based on the EORTC-QLQ-C30, whichever occurred first. EORTC-QLQ-C30 questionnaire is a standardized instrument developed to assess the quality of life of people with cancer. EORTC-QLQ-C30 functional subscale includes 5 items: physical, role, emotional, cognitive, and social functioning. All of the single items of functional status subscale measures and global health status/QOL subscale range from 0 to 100, where higher scores represent a better level of functioning/quality of life.
Time Frame
Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])
Title
Time to Deterioration in Disease Specific Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
Description
Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the symptom score based on the EORTC-QLQ-BR23, whichever occurred first. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much) within each scale.
Time Frame
Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Marin Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7349
Country
United States
Facility Name
TRIO-US Central Administration
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Women's Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCLA Hematology Oncology- Porter Ranch
City
Porter Ranch
State/Province
California
ZIP/Postal Code
91326
Country
United States
Facility Name
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
University of California, San Francisco: Helen Diller Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCLA Hematology-Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sylvester at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Hospital & Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Memorial Breast Cancer Center at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Sylvester at Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
ICRC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5116
Country
United States
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Drug Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sidney & Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Springmill Medical Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Anne Arundel Medical Center (AAMC), Research Pharmacy
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Anne Arundel Medical Center (AAMC)
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Memorial Sloan Kettering Evelyn H. Lauder Breast Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Centre Oscar Lambret
City
Lille Cédex
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273 Cedex 9
Country
France
Facility Name
Hopital Prive du Confluent
City
Nantes BP 20215
ZIP/Postal Code
44202 Cedex 2
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg - Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091Cedex
Country
France
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059 Cedex 9
Country
France
Facility Name
CHU Bretonneau Centre Henry Kaplan
City
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum
City
Muenchen
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen
City
Muenchen
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
University of Munich (LMU) Grosshadern Hospital
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Mutterhaus Der Borromaeerinnen Ggmbh
City
Trier
State/Province
Rheinland-pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
University Hospital Carl Gustav Carus
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
University Hospital Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
g.SUND Gynaekologie Kompetenzzentrum Stralsund
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
Facility Name
Universitaets-Frauenklinik
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Center International Espana
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario San Juan de Alicante
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Cambridge University Hospital NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
England
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
30563931
Citation
Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmana J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. doi: 10.1158/1078-0432.CCR-18-1891. Epub 2018 Dec 18.
Results Reference
derived
Learn more about this trial
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)
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