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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
Date last updated
20/01/2021

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
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Arizona
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California
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Delaware
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Florida
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Illinois
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Indiana
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Kansas
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Maryland
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Michigan
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Minnesota
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Wisconsin
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Belgium
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Bruxelles-Capitale
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Belgium
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Hainaut
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Kortrijk
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Belgium
State/province [32] 0 0
Namur
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Canada
State/province [33] 0 0
Ontario
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Canada
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Quebec
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Czechia
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Olomoucky Kraj
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Czechia
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Brno
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Czechia
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Hradec Kralove
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France
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Haute-Garonne
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France
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Hauts-de-France
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France
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Ile-de-France
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France
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Rhone
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France
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Clermont Ferrand
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France
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Paris
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France
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Saint-cloud
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Bremen
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Germany
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Dortmund
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Germany
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Esslingen
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Germany
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Frankfurt
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Germany
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Fürth
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Germany
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Gelsenkirchen
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Germany
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Kassel
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Germany
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Limburg
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Germany
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Munich
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Germany
State/province [59] 0 0
Offenbach
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Germany
State/province [60] 0 0
Schweinfurt
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Germany
State/province [61] 0 0
Stendal
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Germany
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Wiesbaden
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Germany
State/province [63] 0 0
Witten
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Kecskemét
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Hungary
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Miskolc
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Hungary
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Szeged
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Hungary
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Szolnok
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Italy
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Emilia-Romagna
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Italy
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Grosseto
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Italy
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Meldola
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Italy
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Milan
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Italy
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Pavia
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
State/province [78] 0 0
Seoul
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Netherlands
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Amsterdam
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Russian Federation
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Moskva
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Arkhangelsk
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Russian Federation
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Obninsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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St. Petersburg
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Spain
State/province [86] 0 0
A Coruna
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Spain
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Barcelona
Country [88] 0 0
Spain
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT02032277
Trial related presentations / publications
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.
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. doi: 10.1001/jamasurg.2021.0396.
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.
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02032277