Study Stopped
This study was terminated based on Pfizer's change in clinical development strategy not related to safety and efficacy.
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
2 other identifiers
interventional
61
1 country
97
Brief Summary
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2018
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2020
CompletedResults Posted
Study results publicly available
November 9, 2021
CompletedNovember 9, 2021
October 1, 2021
2.1 years
April 9, 2018
August 20, 2021
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Secondary Outcomes (58)
Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator
Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
- +53 more secondary outcomes
Study Arms (1)
TALAZOPARIB
EXPERIMENTALSINGLE ARM, NON-RANDOMIZED
Interventions
Eligibility Criteria
You may qualify if:
- Germline BRCA 1/2 Mutation Positive
- Women and men at least 18 years of age or older.
- Histologically confirmed invasive adenocarcinoma of the breast
- HER2 negative breast cancer as defined by ASCO-CAP criteria
- Tumor greater than or equal toT1, N0-3
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
- ECOG performance status 0 or 1
You may not qualify if:
- Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
- Evidence of distant metastasis apparent prior to randomization
- Patients with inflammatory breast carcinoma
- Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
- Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
- Prior treatment with a PARP inhibitor in any disease setting
- Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
- Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol
- Major surgery within 14 days prior to study entry
- Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
- Active clinically significant infection
- Clinically significant bleeding diathesis or coagulopathy
- Non healing wound, ulcer or bone fracture
- Known hypersensitivity to any of the components of talazoparib
- Patients with myelodysplastic syndrome/acute myeloid leukemia
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (97)
Banner Gateway Medical Center
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
Camarillo, California, 93010, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010, United States
The Oncology Institute of Hope & Innovation
Glendale, California, 91204, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
The Oncology Institute of Hope & Innovation
Long Beach, California, 90805, United States
UC Irvine Health
Orange, California, 92868-3201, United States
UC Irvine Medical Center
Orange, California, 92868-3201, United States
PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Emad Ibrahim, MD, INC.
Redlands, California, 92373, United States
The Oncology Institute of Hope & Innovation
Santa Ana, California, 92705, United States
Stanford Cancer Institute
Stanford, California, 94305, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Stanford Women's Cancer Center
Stanford, California, 94305, United States
PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
Ventura, California, 93003, United States
The Oncology Institute of Hope & Innovation
West Covina, California, 91790, United States
The Oncology Institute of Hope & Innovation
Whittier, California, 90602, United States
ICRI
Whittier, California, 90603, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120-4413, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Innovative Medical Research of South Florida, Inc
Aventura, Florida, 33180, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Rush University Medical Center, Professional Office Building Infusion Pharmacy
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Rush Oak Park Hospital
Oak Park, Illinois, 60304, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39213, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Summit Medical Group PA
Florham Park, New Jersey, 07932, United States
St. Luke's Hospital - Warren Campus
Phillipsburg, New Jersey, 08865, United States
St. Luke's Warren Physician Group
Phillipsburg, New Jersey, 08865, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
St. Luke's Hematology Oncology Specialists
Allentown, Pennsylvania, 18104, United States
St. Luke's Hospital - Allentown Campus
Allentown, Pennsylvania, 18104, United States
St. Luke's Hematology Oncology Specialists
Bethlehem, Pennsylvania, 18015, United States
St. Luke's Hospital - Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
St. Luke's Hospital - Miners Campus
Coaldale, Pennsylvania, 18218, United States
St Luke's Hospital - Anderson Campus
Easton, Pennsylvania, 18045, United States
St. Luke's Hospital - Anderson Campus
Easton, Pennsylvania, 18045, United States
UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Cancer Centers East Oxford Drive
Monroeville, Pennsylvania, 15146, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center North Hills at Passavant
Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
St. Luke's Hospital - Quakertown Campus
Quakertown, Pennsylvania, 18951, United States
St. Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, 18360, United States
UPMC Hillman Cancer Center Uniontown
Uniontown, Pennsylvania, 15401, United States
UPMC Hillman Cancer Center Washington
Washington, Pennsylvania, 15301, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Avera Specialty Hospital
Sioux Falls, South Dakota, 57108, United States
Brig Center for Cancer Care and Survivorship
Knoxville, Tennessee, 37909, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Texas Oncology - Allen
Allen, Texas, 75013, United States
Texas Oncology - Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology-Austin Central
Austin, Texas, 78731, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Denton South
Denton, Texas, 76210, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
Houston, Texas, 77030, United States
U.T. MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Texas Oncology - McKinney
McKinney, Texas, 75071, United States
Texas Oncology - Round Rock
Round Rock, Texas, 78681, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98683, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792, United States
UW Health University Hospital - Pharmaceutical Research Center
Madison, Wisconsin, 53792, United States
Related Publications (2)
Litton JK, Beck JT, Jones JM, Andersen J, Blum JL, Mina LA, Brig R, Danso M, Yuan Y, Abbattista A, Noonan K, Niyazov A, Chakrabarti J, Czibere A, Symmans WF, Telli ML. Neoadjuvant Talazoparib in Patients With Germline BRCA1/2 Mutation-Positive, Early-Stage Triple-Negative Breast Cancer: Results of a Phase II Study. Oncologist. 2023 Oct 3;28(10):845-855. doi: 10.1093/oncolo/oyad139.
PMID: 37318349DERIVEDLitton JK, Scoggins ME, Hess KR, Adrada BE, Murthy RK, Damodaran S, DeSnyder SM, Brewster AM, Barcenas CH, Valero V, Whitman GJ, Schwartz-Gomez J, Mittendorf EA, Thompson AM, Helgason T, Ibrahim N, Piwnica-Worms H, Moulder SL, Arun BK. Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant. J Clin Oncol. 2020 Feb 10;38(5):388-394. doi: 10.1200/JCO.19.01304. Epub 2019 Aug 28.
PMID: 31461380DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated by the sponsor due to a change in clinical development strategy not related to safety or efficacy after all participants completed safety follow-up.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 17, 2018
Study Start
August 27, 2018
Primary Completion
September 23, 2020
Study Completion
September 23, 2020
Last Updated
November 9, 2021
Results First Posted
November 9, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
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.