AzTrials
AzTrials

Breast TumorPhase 2/3tnAcityNCT01881230

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

A Phase 2/3 study testing nab-Paclitaxel, Carboplatin and Gemcitabine in people with Breast Tumor and Breast Cancer, run by Celgene at 140 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Tumor, Breast Cancer, Cancer of the Breast
What is being tested?
nab-Paclitaxel, Carboplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
140 sitesin 12 countries
Study dates
26 Sep 2013to 28 Oct 2016
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Male subjects
  • Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy \& monoclonal antibody therapy are acceptable.
  • Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
  • History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
  • Subjects with bone as the only site of metastatic disease
Show all 21Show fewer
  • Subjects with regional lymph node as the only site of metastatic disease
  • Serious intercurrent medical or psychiatric illness, including serious active infection
  • History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
  • History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
  • Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications
  • Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
  • Subjects who have received an investigational product within the previous 4 weeks prior to randomization
  • Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
  • Pregnant or nursing women
  • Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
  • Any condition that confounds the ability to interpret data from the study
  • History of seropositive human immunodeficiency virus (HIV)
  • Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications

Trial locations and contacts

140 sites in 12 countries.

140 sites in 12 countries

United States64 sites

  • Pacific Cancer Medical Center Inc

    Anaheim, California, 92801

  • University of Maryland School of Med

    Baltimore, Maryland, 21201

  • Center for Cancer and Blood Disorders, PC

    Bethesda, Maryland, 20817

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Alamance Regional Medical Cancer Center

    Burlington, North Carolina, 27215-8700

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • University of Cincinnatti

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • North Bend Medical Center

    Coos Bay, Oregon, 97420

  • Texas Oncology, PA

    Dallas, Texas, 75231

  • Texas Oncology, PA- Dallas

    Dallas, Texas, 75246

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan, 48202-268

  • Hematology Oncology Associates of CNY

    East Syracuse, New York, 13057

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • California Cancer Associates for Research and Excellence cCARE

    Escondido, California, 92025

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Memorial Breast Cancer Center

    Hollywood, Florida, 33021

  • New Hampshire Oncology Hematology

    Hooksett, New Hampshire, 03106

  • UT Physicians General Medicine

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46254

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Ltd

    Joliet, Illinois, 60435

  • Midwest Physicians Group

    Kansas City, Missouri, 64132

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Wilshire Oncology Medical Group, Inc

    La Verne, California, 91750

  • University of South Alabama Mitchell Cancer Institute

    Lafayette, Louisiana, 70503

  • NYU Langone Arena Oncology

    Lake Success, New York, 11042

  • St Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Translational Research Management

    Los Angeles, California, 90045

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Columbia St Marys Cancer Center

    Milwaukee, Wisconsin, 53211

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55407

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Clinical Research Alliance

    New York, New York, 10021

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Northwest Cancer Specialists, P.C. - Hoyt

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Delta Hematologyoncology Associates

    Portsmouth, Virginia, 23704

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Cancer Care Centers of South Texas - Loop

    San Antonio, Texas, 78217

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Redwood Regional Medical Group, INC

    Santa Rosa, California, 95403

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Arizona Cancer Research Alliance

    Scottsdale, Arizona, 85251

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Toledo Community Oncology Program

    Toledo, Ohio, 43623

  • Texas Oncology P.A.- Tyler

    Tyler, Texas, 75702

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

Other trials in United States

Italy16 sites

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna

    Ferrara, 44124

  • IRCCS AziendaOspedaliera Universitaria San Martino

    Genova, 16132

  • Presidio Ospedaliero della Misericordia

    Grosseto, 58100

  • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

    Messina, 98158

  • Azienda Ospedaliera San Gerardo

    Monza, 20900

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, Campania, 80131

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    Napoli, Campania, 80131

  • Istituto Oncologico Veneto

    Padova, 35128

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Policlinico Universitario A Gemelli

    Roma, 00168

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Istituto Nazionale Tumori Regina Elena

    Roma, 144

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, Piemonte, 10126

  • Azienda Ospedaliera Treviglio-Caravaggio

    Treviglio, 24047

Other trials in Italy

Brazil15 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Liga Paranaense de Combate Ao Cancer

    Curitiba, Paraná, 81520-060

  • ONCOCLINIC Clinica de Oncologia LTDA

    Fortaleza, 60160-230

  • Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

    Jau/SP, São Paulo, 17210-080

  • Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Ribeiraopretano de Combate Ao Cancer

    Ribeirão Preto, 14015-130

  • Hospital das Clinicas da Faculdade de Medicina da USP

    Ribeirão Preto, 14048-900

  • Instituto Nacional de Cancer - INCA

    Rio de Janerio, Rio de Janeiro, 20560-120

  • Hospital Bruno Born

    Rio Grande, 95900-000

  • Centro de Oncologia Da Bahia

    Salvador, Estado de Bahia, 41820-021

  • Hospital de Base Da Faculdade de Medicina de

    São José do Rio Preto, 15090-000

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308-050

  • Instituto Brasileiro de Controle Do Cancer IBCC

    São Paulo, 03102-002

  • Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

    São Paulo, 05651-901

Other trials in Brazil

Germany10 sites

  • Sankt Gertrauden-Krankenhaus

    Berlin, 10713

  • Facharztpraxis fur Gynakologie und Geburtshilfe

    Bonn, 53111

  • Schwerpunktpraxis fur Gynakologische Onkologie

    Cologne, 50679

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • Praxis fur interdisziplinare Onkologie & Hamatologie

    Freiburg im Breisgau, 79110

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Frauenarzte am Bahnhofsplatz

    Hildesheim, 31134

  • LMU Klinikum der Universitat

    München, 81377

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, 54290

  • Universitatsklinikum Ulm

    Ulm, 89075

Other trials in Germany

Spain8 sites

  • Clinic Barcelona Hospital Universitari

    Barcelona, 08036

  • Hospital Universitario Vall D Hebron

    Barcelona, 8035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Onkologikoa - Kutxaren Institutu Onkologikoa

    Donostia / San Sebastian, 20014

  • Hospital General Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Canada5 sites

  • CHUM - Notre Dame

    Montreal, Quebec, H2L 4M1

  • Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6

  • Hospital du Saint Scarement Sacrement Laboratory

    Québec, Quebec, G1S4L8

  • Alan Blair Cancer Centre at Pasqua Hosptial

    Regina, Saskatchewan, S4T1A5

  • CSSS de Rimouski Neigette

    Rimouski, Quebec, G5L5T1

Other trials in Canada

Greece5 sites

  • University of Athens Medical school - Regional General Hospital

    Athens, 11528

  • IASO General

    Athens, 15562

  • Metropolitan Hospital

    Faliro, 18547

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University General Hospital of Patras

    Rio Patras, 26500

Other trials in Greece

United Kingdom5 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The East and North Hertfordshire NHS Trust

    Middlesex, HA62RN

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield South Yorkshire, S10 2SJ

Other trials in United Kingdom

Australia4 sites

  • Frankston Hospital Oncology Research

    Frankston, Victoria, 3199

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

Portugal4 sites

  • Hospital Espirito Santo

    Evora, 7000-811

  • Hospital Da Luz

    Lisbon, 1500-650

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto, Francisco Gentil

    Porto, 4200-072

Other trials in Portugal

Austria3 sites

  • Universitaetsklinik Innsbruck

    Innsbruck, 6020

  • Salzburger Landkliniken St. Johanns-Spital

    Salzburg, 5020

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

France1 site

  • Centre Jean Perrin

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

Read the detailed description

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer.

Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.

Keywords
Breast Cancer, Cancer of the Breast, Metastatic Breast Cancer, Metastatic Triple Negative Breast Cancer, Triple Negative Breast Cancer, Triple Negative Metastatic Breast Cancer, Basal-like breast cancer, Hormone receptor negative breast cancer, Estrogen receptor negative breast cancer, Progesterone negative receptor breast cancer, HER2 Negative Breast Cancer, Abraxane, nab-Paclitaxel, ABI-007, gemcitabine, Gemzar, carboplatin, Paraplatin, Paraplatin AQ, Phase 2
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-PaclitaxelDrug

    Also called Abraxane

    nab-Paclitaxel 125 mg/m^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.

  • CarboplatinDrug

    Also called Paraplatin,, Paraplatin AQ

    Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.

Study groups in NCT01881230
Study groupRoleWhat they receive
nab-Paclitaxel plus GemcitabineExperimentalTreatment Arm A: nab-Paclitaxel 125 mg/m^2 by intravenous (IV) administration over 30 minutes, followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle by IV administration over 30 minutes
Receives: Drug: nab-Paclitaxel; Drug: Gemcitabine
nab-Paclitaxel plus CarboplatinExperimentalTreatment Arm B: nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin at an Area Under the Curve (AUC) of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Receives: Drug: nab-Paclitaxel; Drug: Carboplatin
Gemcitabine plus CarboplatinActive comparatorTreatment Arm C: Gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin AUC 2 on Days 1 and 8 of each 21-day cycle by IV administration
Receives: Drug: Carboplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.

    PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.

    Measured: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

Secondary outcomes (6)

  1. Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.

    Percentage of participants with an Objective Complete or Partial Overall Response according to RECIST 1.1 and defined as: Complete response-disappearance of all target lesions; partial response at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.

    Measured: Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

  2. Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy

    The percentage of participants who initiated Cycle 6 receiving doublet combination therapy regardless of the need for dose modifications.

    Measured: Cycle 6

  3. Kaplan-Meier Estimates of Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of death (from any cause).

    Measured: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

  4. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Treatment-emergent adverse events (TEAEs) were defined as any AEs that began or worsened with the onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death.

    Measured: From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

  5. Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)

    The number of participants with dose modifications occurring during the treatment period. Dose reductions and interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.

    Measured: From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

  6. Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs

    Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose.

    Measured: From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study start26 Sep 2013
  3. Primary completion28 Oct 2016
  4. Study completion28 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01881230
Sponsor's protocol ID
ABI-007-MBC-001
Other IDs
2013-000113-20
Acronym
tnAcity
Status last verified
Feb 2019
First submitted
17 Jun 2013
Last updated
21 Feb 2019
Data monitoring committee
Yes

Publications

  • Yardley DA, Brufsky A, Coleman RE, Conte PF, Cortes J, Gluck S, Nabholtz JM, O'Shaughnessy J, Beck RM, Ko A, Renschler MF, Barton D, Harbeck N. Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial. Trials. 2015 Dec 16;16:575. doi: 10.1186/s13063-015-1101-7.

    PubMed 26673577

  • Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R. First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial. Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

    PubMed 31849532

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing nab-Paclitaxel, Carboplatin and Gemcitabine in people with Breast Tumor and Breast Cancer, run by Celgene at 140 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Italy, Brazil, Germany, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment. (time frame: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01881230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

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