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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cyclophosphamide
Placebo
Doxorubicin
Paclitaxel
Carboplatin
Veliparib
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Oncology, Triple negative breast cancer, German Breast Group - GBG 81, United States Oncology - 12152, National Surgical Adjuvant Breast and Bowel Project - B-56-I, Alliance - AFT-04, Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
  2. Documented Breast Cancer Gene (BRCA) germline mutation testing.
  3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
  4. ECOG Performance status of 0 to 1.
  5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

  1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
  2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
  3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
  4. A history of seizure within 12 months prior to study entry.
  5. Pre-existing neuropathy from any cause in excess of Grade 1.

Sites / Locations

  • Scottsdale Healthcare /ID# 120473
  • Mayo Clinic - Scottsdale /ID# 139932
  • Arizona Oncology Associates, PC-HOPE /ID# 126137
  • Usc /Id# 123310
  • Pacific Cancer Care /ID# 120476
  • Sharp Memorial Hospital /ID# 119861
  • Stanford University School of Med /ID# 130316
  • Cedars-Sinai Medical Center - West Hollywood /ID# 137275
  • Christiana Care Health Service /ID# 137823
  • Florida Cancer Specialists - Fort Myers /ID# 121835
  • Florida Cancer Specialists - Fort Myers /ID# 126379
  • Mayo Clinic /ID# 132349
  • Mount Sinai Comp Cancer Ctr /ID# 133008
  • Miami Cancer Institute - Baptist Health South Florida /ID# 126145
  • UF Health Cancer Center /ID# 141589
  • Moffitt Cancer Center /ID# 124063
  • University of Illinois - Chicago /ID# 134329
  • Northwestern University Feinberg School of Medicine /ID# 133848
  • University of Chicago DCAM /ID# 120467
  • Loyola University Medical Ctr /ID# 120455
  • OSF St. Anthony Medical Center /ID# 139424
  • Indiana Univ School Medicine /ID# 118215
  • Community Rgnal Cancer Care N /ID# 120456
  • Horizon Oncology Research Center /ID# 116815
  • Cancer Center of Kansas /ID# 134720
  • Univ Maryland School Medicine /ID# 119235
  • St. Joseph Mercy Hospital /ID# 135875
  • Minnesota Oncology Hematology, PA /ID# 126144
  • St. Lukes Cancer Institute /ID# 118775
  • Comprehensive Cancer Ctrs Neva /ID# 126136
  • Solinksy Center for Cancer Care /ID# 131970
  • Rutgers Cancer Institute of NJ /ID# 120477
  • Columbia Univ Medical Center /ID# 141588
  • Hope Womens Cancer Centers /ID# 119179
  • Univ NC Chapel Hill /ID# 132893
  • Univ NC Chapel Hill /ID# 147695
  • Novant Health Oncology Special /ID# 139890
  • Sanford Roger Maris Cancer Cen /ID# 132394
  • Oncology Hematology Care, Inc - Blue Ash /ID# 120478
  • University Hospitals Case Medical Center /ID# 141691
  • Fairview Hospital /ID# 141626
  • Cleveland Clinic Main Campus /ID# 126378
  • The Ohio State University /ID# 141587
  • Lehigh Valley Health Network /ID# 133372
  • Guthrie Medical Group, PC /ID# 124397
  • Women and Infants Hospital /ID# 123476
  • Avera Cancer Institute /ID# 120466
  • Tennessee Oncology, PLLC /ID# 124566
  • Texas Oncology - Bedford /ID# 126135
  • Texas Oncology - Medical City Dallas /ID# 126140
  • Texas Oncology - Medical City Dallas /ID# 126141
  • UT Southwestern Medical Center /ID# 133849
  • The Ctr for Cancer and Blood D /ID# 120479
  • Texas Oncology - Memorial City /ID# 126139
  • Texas Oncology - Plano East /ID# 126143
  • Texas Oncology - Tyler /ID# 126142
  • University of Utah /ID# 118677
  • University of Virginia /ID# 122975
  • Virginia Commonwealth Univ /ID# 141586
  • Virginia Oncology Associates /ID# 127260
  • Univ of Wisconsin Hosp/Clinics /ID# 120457
  • The Tweed Hospital /ID# 120235
  • Cabrini Health /ID# 120236
  • Royal Melbourne Hospital /ID# 127717
  • Western Health Sunshine Hosp. /ID# 120715
  • Fiona Stanley Hospital /ID# 120716
  • St. John of God Hosp - Murdoch /ID# 131788
  • St. John of God Subiaco Hosp /ID# 120717
  • Cliniques Universitaires Saint Luc /ID# 120719
  • Grand Hôpital de Charleroi /ID# 116678
  • CHU Brugmann /ID# 120376
  • UZ Antwerp /ID# 120720
  • AZ Groeninge /ID# 120718
  • CHU UCL Namur /ID# 116677
  • Sunnybrook Health Sciences Ctr /ID# 123312
  • Jewish General Hospital /ID# 141629
  • CHUM - Notre-Dame Hospital /ID# 141694
  • CHUQ-Hospital St. Sacrement /ID# 141619
  • Fakultni Nemocnice Olomouc /ID# 120725
  • Masarykuv onkologikcy ustav /ID# 120726
  • FN Hradec Kralove /ID# 120596
  • Hopital Universitaire Purpan /ID# 120731
  • Centre Oscar Lambret /ID# 119958
  • Institut Curie /ID# 116679
  • Centre Leon Berard /ID# 120740
  • Jean Perrin Centre /ID# 125277
  • Hosp European, Georges Pompid /ID# 120736
  • Hopital Rene Huguenin /ID# 120729
  • Universitaetsklinikum Schleswig-Holstein /ID# 133454
  • Universitaetsklinikum Ulm /ID# 133453
  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472
  • Helios Klinikum Berlin Buch /ID# 133465
  • Studiengesellschaft Onk Bielef /ID# 133471
  • Klinikum Bremen Mitte gGmbH /ID# 132875
  • St. Johannes Hospital /ID# 133478
  • Kliniken Esslingen /ID# 133475
  • Klinikum Frankfurt Hoechst /ID# 145301
  • Wilke/Wagner/Petzoldt, Fuerth /ID# 133481
  • Evangelisches Krankenhaus /ID# 133457
  • Elisabeth Krankenhaus /ID# 133461
  • St. Vincenz Krankenhaus /ID# 133466
  • Onk Zentrum am Rotkreuz /ID# 133482
  • Klinikum recht der Isar der TU /ID# 133449
  • Sana Klinikum Offenbach /ID# 133455
  • Leopoldina-Krankenhaus /ID# 133484
  • Johanniter-Krankenhaus Genthin /ID# 133463
  • St. Josefs-Hospital /ID# 133464
  • Marienhospital Witten /ID# 133470
  • National Institute of Oncology /ID# 120828
  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834
  • Uzsoki Utcai Korhaz /ID# 120825
  • Debreceni Egyetem Klinikai Kozpont /ID# 116681
  • Petz Aladar Megyei Oktato Korh /ID# 120835
  • Bacs-Kiskun Megyei Korhaz /ID# 120833
  • BAZ Megyei E.O. Korhaz /ID# 122215
  • University of Szeged /ID# 120823
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818
  • A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855
  • Misericordia General Hospital /ID# 119536
  • IRCCS-I.R.S.T. srl Meldola /ID# 120255
  • Istituto Europeo di Oncologia /ID# 120845
  • IRCCS Fondazione Salva Maugeri /ID# 120848
  • National Cancer Center /ID# 119525
  • Ajou University Hospital /ID# 118856
  • Kyungpook National University Chilgok Hospital /ID# 118855
  • Severance Hospital /ID# 116699
  • Samsung Medical Center /ID# 119276
  • Korea University Anam Hospital /ID# 118857
  • Seoul National University Hospital /ID# 116698
  • Asan Medical Center /ID# 116696
  • Vrije Universiteit Medisch Centrum /ID# 126302
  • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944
  • Kursk Regional Oncology Dispen /ID# 116688
  • archangel Clinical Oncology /ID# 120935
  • Medical Radiological Res Ctr /ID# 124017
  • Pyatigorsk Oncology Dispensary /ID# 120945
  • Leningrad Reg Onc Dispensery /ID# 120938
  • Birch A Healthcare /ID# 116695
  • Hospital Universitario A Coruña - CHUAC /ID# 135108
  • Hospital Universitario Germans Trias i Pujol /ID# 135112
  • Hospital General Universitario Alicante /ID# 135115
  • Hospital Parc de Salut del Mar /ID# 135110
  • Hospital Santa Creu i Sant Pau /ID# 145400
  • Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979
  • Hospital Universitario Ramon y Cajal /ID# 135113
  • Hospital Clinico Universitario San Carlos /ID# 119959
  • Hospital Universitario Virgen del Rocio /ID# 135114
  • Fundacion Instituto Valenciano Oncologia IVO /ID# 135116
  • Hospital Clinico Universitario de Valencia /ID# 123076
  • Hospital General Universitario de Valencia /ID# 135111
  • Hospital Universitario Miguel Servet /ID# 119195
  • National Taiwan Univ Hosp /ID# 122895
  • Changhua Christian Hospital /ID# 119085
  • Chi Mei Hospital - Liouying /ID# 120982
  • Univ Hosp Bristol NHS Foundati /ID# 120989
  • Charing Cross Hospital /ID# 120990
  • Nottingham Univ Hospitals NHS /ID# 122218
  • Royal Stoke Univ Hospital /ID# 120984

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Arm A

Arm C

Arm B

Arm Description

Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

Placebo + placebo + paclitaxel followed by AC.

Placebo + carboplatin + paclitaxel followed by AC

Outcomes

Primary Outcome Measures

Pathological Complete Response (pCR).
Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.

Secondary Outcome Measures

Event Free Survival (EFS)
EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause.
Overall Survival (OS)
OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.
Rate of eligibility for breast conservation after therapy (BCR).
Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.

Full Information

First Posted
December 13, 2013
Last Updated
January 15, 2021
Sponsor
AbbVie
Collaborators
German Breast Group, NSABP Foundation Inc, Grupo Español de Investigación del Cáncer de Mama, US Oncology Research
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1. Study Identification

Unique Protocol Identification Number
NCT02032277
Brief Title
A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2014 (Actual)
Primary Completion Date
March 18, 2016 (Actual)
Study Completion Date
November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
German Breast Group, NSABP Foundation Inc, Grupo Español de Investigación del Cáncer de Mama, US Oncology Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Oncology, Triple negative breast cancer, German Breast Group - GBG 81, United States Oncology - 12152, National Surgical Adjuvant Breast and Bowel Project - B-56-I, Alliance - AFT-04, Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Placebo + placebo + paclitaxel followed by AC.
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Placebo + carboplatin + paclitaxel followed by AC
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Carboplatin
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Veliparib
Other Intervention Name(s)
ABT-888
Intervention Description
Veliparib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Veliparib
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR).
Description
Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.
Time Frame
At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Secondary Outcome Measure Information:
Title
Event Free Survival (EFS)
Description
EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause.
Time Frame
Up to 4 years from the date of definitive surgery.
Title
Overall Survival (OS)
Description
OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.
Time Frame
Up to 4 years from the date of definitive surgery.
Title
Rate of eligibility for breast conservation after therapy (BCR).
Description
Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.
Time Frame
At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies. Documented Breast Cancer Gene (BRCA) germline mutation testing. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast. ECOG Performance status of 0 to 1. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization. Exclusion Criteria: Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment. A history of seizure within 12 months prior to study entry. Pre-existing neuropathy from any cause in excess of Grade 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare /ID# 120473
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4566
Country
United States
Facility Name
Mayo Clinic - Scottsdale /ID# 139932
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Oncology Associates, PC-HOPE /ID# 126137
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711-2701
Country
United States
Facility Name
Usc /Id# 123310
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pacific Cancer Care /ID# 120476
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Sharp Memorial Hospital /ID# 119861
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University School of Med /ID# 130316
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Cedars-Sinai Medical Center - West Hollywood /ID# 137275
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Christiana Care Health Service /ID# 137823
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers /ID# 121835
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers /ID# 126379
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Mayo Clinic /ID# 132349
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Comp Cancer Ctr /ID# 133008
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Miami Cancer Institute - Baptist Health South Florida /ID# 126145
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
UF Health Cancer Center /ID# 141589
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt Cancer Center /ID# 124063
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
University of Illinois - Chicago /ID# 134329
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 133848
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
University of Chicago DCAM /ID# 120467
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Loyola University Medical Ctr /ID# 120455
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
OSF St. Anthony Medical Center /ID# 139424
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Indiana Univ School Medicine /ID# 118215
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Rgnal Cancer Care N /ID# 120456
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Horizon Oncology Research Center /ID# 116815
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Cancer Center of Kansas /ID# 134720
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Univ Maryland School Medicine /ID# 119235
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St. Joseph Mercy Hospital /ID# 135875
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Minnesota Oncology Hematology, PA /ID# 126144
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Lukes Cancer Institute /ID# 118775
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111-5905
Country
United States
Facility Name
Comprehensive Cancer Ctrs Neva /ID# 126136
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Solinksy Center for Cancer Care /ID# 131970
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Rutgers Cancer Institute of NJ /ID# 120477
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 141588
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Hope Womens Cancer Centers /ID# 119179
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28816
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 132893
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 147695
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
Novant Health Oncology Special /ID# 139890
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sanford Roger Maris Cancer Cen /ID# 132394
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Oncology Hematology Care, Inc - Blue Ash /ID# 120478
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45252
Country
United States
Facility Name
University Hospitals Case Medical Center /ID# 141691
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Fairview Hospital /ID# 141626
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 126378
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 141587
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lehigh Valley Health Network /ID# 133372
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Guthrie Medical Group, PC /ID# 124397
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Women and Infants Hospital /ID# 123476
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Avera Cancer Institute /ID# 120466
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Tennessee Oncology, PLLC /ID# 124566
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Bedford /ID# 126135
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Medical City Dallas /ID# 126140
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Medical City Dallas /ID# 126141
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 133849
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
The Ctr for Cancer and Blood D /ID# 120479
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology - Memorial City /ID# 126139
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology - Plano East /ID# 126143
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology - Tyler /ID# 126142
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Utah /ID# 118677
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
University of Virginia /ID# 122975
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth Univ /ID# 141586
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Oncology Associates /ID# 127260
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Univ of Wisconsin Hosp/Clinics /ID# 120457
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
The Tweed Hospital /ID# 120235
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Cabrini Health /ID# 120236
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Royal Melbourne Hospital /ID# 127717
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Western Health Sunshine Hosp. /ID# 120715
City
St. Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 120716
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
St. John of God Hosp - Murdoch /ID# 131788
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
St. John of God Subiaco Hosp /ID# 120717
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Cliniques Universitaires Saint Luc /ID# 120719
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hôpital de Charleroi /ID# 116678
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU Brugmann /ID# 120376
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Antwerp /ID# 120720
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Groeninge /ID# 120718
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU UCL Namur /ID# 116677
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sunnybrook Health Sciences Ctr /ID# 123312
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital /ID# 141629
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHUM - Notre-Dame Hospital /ID# 141694
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
CHUQ-Hospital St. Sacrement /ID# 141619
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Fakultni Nemocnice Olomouc /ID# 120725
City
Olomouc
State/Province
Olomoucky Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Masarykuv onkologikcy ustav /ID# 120726
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
FN Hradec Kralove /ID# 120596
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hopital Universitaire Purpan /ID# 120731
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Oscar Lambret /ID# 119958
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59020
Country
France
Facility Name
Institut Curie /ID# 116679
City
Paris CEDEX 05
State/Province
Ile-de-France
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Leon Berard /ID# 120740
City
Lyon CEDEX 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Jean Perrin Centre /ID# 125277
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hosp European, Georges Pompid /ID# 120736
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Rene Huguenin /ID# 120729
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein /ID# 133454
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 133453
City
Ulm
State/Province
Thueringen
ZIP/Postal Code
89081
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Helios Klinikum Berlin Buch /ID# 133465
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Studiengesellschaft Onk Bielef /ID# 133471
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum Bremen Mitte gGmbH /ID# 132875
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
St. Johannes Hospital /ID# 133478
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Kliniken Esslingen /ID# 133475
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Klinikum Frankfurt Hoechst /ID# 145301
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Wilke/Wagner/Petzoldt, Fuerth /ID# 133481
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Facility Name
Evangelisches Krankenhaus /ID# 133457
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Elisabeth Krankenhaus /ID# 133461
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
St. Vincenz Krankenhaus /ID# 133466
City
Limburg
ZIP/Postal Code
65549
Country
Germany
Facility Name
Onk Zentrum am Rotkreuz /ID# 133482
City
Munich
ZIP/Postal Code
80634
Country
Germany
Facility Name
Klinikum recht der Isar der TU /ID# 133449
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Sana Klinikum Offenbach /ID# 133455
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Leopoldina-Krankenhaus /ID# 133484
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Facility Name
Johanniter-Krankenhaus Genthin /ID# 133463
City
Stendal
ZIP/Postal Code
39576
Country
Germany
Facility Name
St. Josefs-Hospital /ID# 133464
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Marienhospital Witten /ID# 133470
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
National Institute of Oncology /ID# 120828
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz /ID# 120825
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 116681
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korh /ID# 120835
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz /ID# 120833
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
BAZ Megyei E.O. Korhaz /ID# 122215
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
University of Szeged /ID# 120823
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Misericordia General Hospital /ID# 119536
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
IRCCS-I.R.S.T. srl Meldola /ID# 120255
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia /ID# 120845
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Fondazione Salva Maugeri /ID# 120848
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
National Cancer Center /ID# 119525
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Ajou University Hospital /ID# 118856
City
Suwon-si
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital /ID# 118855
City
Daegu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Severance Hospital /ID# 116699
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 119276
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital /ID# 118857
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 116698
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 116696
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Vrije Universiteit Medisch Centrum /ID# 126302
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Kursk Regional Oncology Dispen /ID# 116688
City
Kursk
State/Province
Tatarstan, Respublika
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
archangel Clinical Oncology /ID# 120935
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Medical Radiological Res Ctr /ID# 124017
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Pyatigorsk Oncology Dispensary /ID# 120945
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Leningrad Reg Onc Dispensery /ID# 120938
City
St. Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Birch A Healthcare /ID# 116695
City
St. Petersburg
ZIP/Postal Code
197183
Country
Russian Federation
Facility Name
Hospital Universitario A Coruña - CHUAC /ID# 135108
City
A Coruña
State/Province
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 135112
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario Alicante /ID# 135115
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 135110
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 145400
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 135113
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 119959
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 135114
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Fundacion Instituto Valenciano Oncologia IVO /ID# 135116
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 123076
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General Universitario de Valencia /ID# 135111
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Miguel Servet /ID# 119195
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
National Taiwan Univ Hosp /ID# 122895
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Changhua Christian Hospital /ID# 119085
City
Changhua County
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Chi Mei Hospital - Liouying /ID# 120982
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
Univ Hosp Bristol NHS Foundati /ID# 120989
City
Bristol
ZIP/Postal Code
BS2 8EG
Country
United Kingdom
Facility Name
Charing Cross Hospital /ID# 120990
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Nottingham Univ Hospitals NHS /ID# 122218
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Stoke Univ Hospital /ID# 120984
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
33599688
Citation
Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE Jr, Bae J, Collier K, Cherian M, O'Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):603-608. doi: 10.1001/jamaoncol.2020.7310.
Results Reference
derived
PubMed Identifier
31913413
Citation
Golshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):e195410. doi: 10.1001/jamasurg.2019.5410. Epub 2020 Mar 18. Erratum In: JAMA Surg. 2021 May 1;156(5):503.
Results Reference
derived
PubMed Identifier
31606288
Citation
Golshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial. Eur J Surg Oncol. 2020 Feb;46(2):223-228. doi: 10.1016/j.ejso.2019.10.002. Epub 2019 Oct 5.
Results Reference
derived
PubMed Identifier
29501363
Citation
Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.
Results Reference
derived

Learn more about this trial

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

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