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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02032277




Registration number
NCT02032277
Ethics application status
Date submitted
13/12/2013
Date registered
10/01/2014

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2013-002377-21
Secondary ID [2] 0 0
M14-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Placebo
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Veliparib
Treatment: Drugs - Placebo

Active comparator: Arm A - Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)

Placebo comparator: Arm C - Placebo + placebo + paclitaxel followed by AC.

Placebo comparator: Arm B - Placebo + carboplatin + paclitaxel followed by AC


Treatment: Drugs: Cyclophosphamide
Cyclophosphamide

Treatment: Drugs: Placebo
Placebo for Carboplatin

Treatment: Drugs: Doxorubicin
Doxorubicin

Treatment: Drugs: Paclitaxel
Paclitaxel

Treatment: Drugs: Carboplatin
Carboplatin

Treatment: Drugs: Veliparib
Veliparib

Treatment: Drugs: Placebo
Placebo for Veliparib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological Complete Response (pCR).
Timepoint [1] 0 0
At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Secondary outcome [1] 0 0
Event Free Survival (EFS)
Timepoint [1] 0 0
Up to 4 years from the date of definitive surgery.
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 4 years from the date of definitive surgery.
Secondary outcome [3] 0 0
Rate of eligibility for breast conservation after therapy (BCR).
Timepoint [3] 0 0
At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2020
Sample size
Target
Accrual to date
Final
634
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Tweed Hospital /ID# 120235 - Tweed Heads
Recruitment hospital [2] 0 0
Cabrini Health /ID# 120236 - Malvern
Recruitment hospital [3] 0 0
Royal Melbourne Hospital /ID# 127717 - Parkville
Recruitment hospital [4] 0 0
Western Health Sunshine Hosp. /ID# 120715 - St. Albans
Recruitment hospital [5] 0 0
Fiona Stanley Hospital /ID# 120716 - Murdoch
Recruitment hospital [6] 0 0
St. John of God Hosp - Murdoch /ID# 131788 - Murdoch
Recruitment hospital [7] 0 0
St. John of God Subiaco Hosp /ID# 120717 - Subiaco
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
3021 - St. Albans
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles-Capitale
Country [28] 0 0
Belgium
State/province [28] 0 0
Hainaut
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Edegem
Country [31] 0 0
Belgium
State/province [31] 0 0
Kortrijk
Country [32] 0 0
Belgium
State/province [32] 0 0
Namur
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Czechia
State/province [35] 0 0
Olomoucky Kraj
Country [36] 0 0
Czechia
State/province [36] 0 0
Brno
Country [37] 0 0
Czechia
State/province [37] 0 0
Hradec Kralove
Country [38] 0 0
France
State/province [38] 0 0
Haute-Garonne
Country [39] 0 0
France
State/province [39] 0 0
Hauts-de-France
Country [40] 0 0
France
State/province [40] 0 0
Ile-de-France
Country [41] 0 0
France
State/province [41] 0 0
Rhone
Country [42] 0 0
France
State/province [42] 0 0
Clermont Ferrand
Country [43] 0 0
France
State/province [43] 0 0
Paris
Country [44] 0 0
France
State/province [44] 0 0
Saint-cloud
Country [45] 0 0
Germany
State/province [45] 0 0
Schleswig-Holstein
Country [46] 0 0
Germany
State/province [46] 0 0
Thueringen
Country [47] 0 0
Germany
State/province [47] 0 0
Augsburg
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Bielefeld
Country [50] 0 0
Germany
State/province [50] 0 0
Bremen
Country [51] 0 0
Germany
State/province [51] 0 0
Dortmund
Country [52] 0 0
Germany
State/province [52] 0 0
Esslingen
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt
Country [54] 0 0
Germany
State/province [54] 0 0
Fürth
Country [55] 0 0
Germany
State/province [55] 0 0
Gelsenkirchen
Country [56] 0 0
Germany
State/province [56] 0 0
Kassel
Country [57] 0 0
Germany
State/province [57] 0 0
Limburg
Country [58] 0 0
Germany
State/province [58] 0 0
Munich
Country [59] 0 0
Germany
State/province [59] 0 0
Offenbach
Country [60] 0 0
Germany
State/province [60] 0 0
Schweinfurt
Country [61] 0 0
Germany
State/province [61] 0 0
Stendal
Country [62] 0 0
Germany
State/province [62] 0 0
Wiesbaden
Country [63] 0 0
Germany
State/province [63] 0 0
Witten
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Hungary
State/province [65] 0 0
Debrecen
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyor
Country [67] 0 0
Hungary
State/province [67] 0 0
Kecskemét
Country [68] 0 0
Hungary
State/province [68] 0 0
Miskolc
Country [69] 0 0
Hungary
State/province [69] 0 0
Szeged
Country [70] 0 0
Hungary
State/province [70] 0 0
Szolnok
Country [71] 0 0
Italy
State/province [71] 0 0
Emilia-Romagna
Country [72] 0 0
Italy
State/province [72] 0 0
Grosseto
Country [73] 0 0
Italy
State/province [73] 0 0
Meldola
Country [74] 0 0
Italy
State/province [74] 0 0
Milan
Country [75] 0 0
Italy
State/province [75] 0 0
Pavia
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Gyeonggido
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul Teugbyeolsi
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Seoul
Country [79] 0 0
Netherlands
State/province [79] 0 0
Amsterdam
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moskva
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Tatarstan, Respublika
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Arkhangelsk
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Obninsk
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Pyatigorsk
Country [85] 0 0
Russian Federation
State/province [85] 0 0
St. Petersburg
Country [86] 0 0
Spain
State/province [86] 0 0
A Coruna
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Alicante
Country [89] 0 0
Spain
State/province [89] 0 0
Lleida
Country [90] 0 0
Spain
State/province [90] 0 0
Madrid
Country [91] 0 0
Spain
State/province [91] 0 0
Sevilla
Country [92] 0 0
Spain
State/province [92] 0 0
Valencia
Country [93] 0 0
Spain
State/province [93] 0 0
Zaragoza
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taipei
Country [95] 0 0
Taiwan
State/province [95] 0 0
Changhua County
Country [96] 0 0
Taiwan
State/province [96] 0 0
Tainan City
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Bristol
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Nottingham
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German Breast Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
NSABP Foundation Inc
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Grupo Español de Investigación del Cáncer de Mama
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
US Oncology Research
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02032277