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)
NCT ID: NCT01881230
Last Updated: 2019-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
191 participants
INTERVENTIONAL
2013-09-26
2016-10-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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nab-Paclitaxel plus Gemcitabine
Treatment 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
nab-Paclitaxel
nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
Gemcitabine
Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.
nab-Paclitaxel plus Carboplatin
Treatment 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
nab-Paclitaxel
nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Gemcitabine plus Carboplatin
Treatment 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
Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Gemcitabine
Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.
Interventions
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nab-Paclitaxel
nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
Carboplatin
Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
Gemcitabine
Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed adenocarcinoma of the breast
3. Pathologically confirmed as triple negative, source documented, defined as both of the following
1. Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: \< 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
2. Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).
4. Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis
5. Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy; unless (a) anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and (b) anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.
a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if anthracycline treatment is not indicated or is not the best treatment option for the subject in the opinion of the treating physician.
6. Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines
7. Life expectancy ≥ 16 weeks from randomization
8. No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.
9. Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed at least 6 months before randomization with all related toxicities resolved, and documented evidence of disease progression per RECIST 1.1 guidelines is required.
a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, or platinum agents, the treatment must have completed at least 12 months before randomization
10. Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
11. At least 30 days from major surgery before randomization, with full recovery
12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
13. Subject has the following blood counts at screening:
* Absolute Neutrophil Count (ANC) ≥ 1500/mm\^2 ;
* Platelets ≥ 100,000/mm\^2 ;
* Hemoglobin (Hgb) ≥ 9 g/dL
14. Subject has the following blood chemistry levels at screening:
* Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x upper limit of normal range (ULN); if hepatic metastases present ≤ 5.0 x ULN
* Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
* Creatinine clearance \> 60 mL/min (by Cockcroft-Gault)
15. Females of child-bearing potential \[defined as a sexually mature women who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)\] must:
* Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and
* Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines
16. Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation
17. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
18. Able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria
1. Male subjects
2. Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy \& monoclonal antibody therapy are acceptable.
3. Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
4. History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
5. Subjects with bone as the only site of metastatic disease
6. Subjects with regional lymph node as the only site of metastatic disease
7. Serious intercurrent medical or psychiatric illness, including serious active infection
8. History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
9. 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.
10. 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
11. Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
12. Subjects who have received an investigational product within the previous 4 weeks prior to randomization
13. 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
14. Pregnant or nursing women
15. Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents
16. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
17. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
18. Any condition that confounds the ability to interpret data from the study
19. History of seropositive human immunodeficiency virus (HIV)
20. Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications
18 Years
FEMALE
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Ileana Elias, M.D.
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
Arizona Center for Cancer Care
Glendale, Arizona, United States
Arizona Cancer Research Alliance
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Pacific Cancer Medical Center Inc
Anaheim, California, United States
California Cancer Associates for Research and Excellence cCARE
Escondido, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Wilshire Oncology Medical Group, Inc
La Verne, California, United States
Translational Research Management
Los Angeles, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Redwood Regional Medical Group, INC
Santa Rosa, California, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Memorial Breast Cancer Center
Hollywood, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States
University of South Alabama Mitchell Cancer Institute
Lafayette, Louisiana, United States
University of Maryland School of Med
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, PC
Bethesda, Maryland, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Midwest Physicians Group
Kansas City, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
New Hampshire Oncology Hematology
Hooksett, New Hampshire, United States
Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Hematology Oncology Associates of CNY
East Syracuse, New York, United States
NYU Langone Arena Oncology
Lake Success, New York, United States
Clinical Research Alliance
New York, New York, United States
Alamance Regional Medical Cancer Center
Burlington, North Carolina, United States
University of Cincinnatti
Cincinnati, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Mark H Zangmeister Center
Columbus, Ohio, United States
Toledo Community Oncology Program
Toledo, Ohio, United States
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, United States
North Bend Medical Center
Coos Bay, Oregon, United States
Northwest Cancer Specialists, P.C. - Hoyt
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
St Mary Medical Center
Langhorne, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Oncology, PA- Dallas
Dallas, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
UT Physicians General Medicine
Houston, Texas, United States
Cancer Care Centers of South Texas - Loop
San Antonio, Texas, United States
Texas Oncology P.A.- Tyler
Tyler, Texas, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Delta Hematologyoncology Associates
Portsmouth, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Medical Oncology Associates
Spokane, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Columbia St Marys Cancer Center
Milwaukee, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Frankston Hospital Oncology Research
Frankston, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Universitaetsklinik Innsbruck
Innsbruck, , Austria
Salzburger Landkliniken St. Johanns-Spital
Salzburg, , Austria
Medizinische Universitat Wien
Vienna, , Austria
Centro de Oncologia Da Bahia
Salvador, Estado de Bahia, Brazil
Liga Paranaense de Combate Ao Cancer
Curitiba, Paraná, Brazil
Instituto Nacional de Cancer - INCA
Rio de Janerio, Rio de Janeiro, Brazil
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
Jau/SP, São Paulo, Brazil
ONCOCLINIC Clinica de Oncologia LTDA
Fortaleza, , Brazil
Instituto Ribeiraopretano de Combate Ao Cancer
Ribeirão Preto, , Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
Ribeirão Preto, , Brazil
Hospital Bruno Born
Rio Grande, , Brazil
Hospital de Base Da Faculdade de Medicina de
São José do Rio Preto, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, , Brazil
Instituto Brasileiro de Controle Do Cancer IBCC
São Paulo, , Brazil
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
São Paulo, , Brazil
Ottawa General Hospital
Ottawa, Ontario, Canada
CHUM - Notre Dame
Montreal, Quebec, Canada
Hospital du Saint Scarement Sacrement Laboratory
Québec, Quebec, Canada
CSSS de Rimouski Neigette
Rimouski, Quebec, Canada
Alan Blair Cancer Centre at Pasqua Hosptial
Regina, Saskatchewan, Canada
Centre Jean Perrin
Clermont-Ferrand, , France
Sankt Gertrauden-Krankenhaus
Berlin, , Germany
Facharztpraxis fur Gynakologie und Geburtshilfe
Bonn, , Germany
Schwerpunktpraxis fur Gynakologische Onkologie
Cologne, , Germany
Agaplesion Markus Krankenhaus
Frankfurt, , Germany
Praxis fur interdisziplinare Onkologie & Hamatologie
Freiburg im Breisgau, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Frauenarzte am Bahnhofsplatz
Hildesheim, , Germany
LMU Klinikum der Universitat
München, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
University of Athens Medical school - Regional General Hospital
Athens, , Greece
IASO General
Athens, , Greece
Metropolitan Hospital
Faliro, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Patras
Rio Patras, , Greece
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, , Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna
Ferrara, , Italy
IRCCS AziendaOspedaliera Universitaria San Martino
Genova, , Italy
Presidio Ospedaliero della Misericordia
Grosseto, , Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
Messina, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Policlinico Universitario A Gemelli
Roma, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Istituto Clinico Humanitas
Rozzano (MI), , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Piemonte, , Italy
Azienda Ospedaliera Treviglio-Caravaggio
Treviglio, , Italy
Hospital Espirito Santo
Evora, , Portugal
Hospital Da Luz
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto, , Portugal
Clinic Barcelona Hospital Universitari
Barcelona, , Spain
Hospital Universitario Vall D Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Onkologikoa - Kutxaren Institutu Onkologikoa
Donostia / San Sebastian, , Spain
Hospital General Gregorio Maranon
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Royal United Hospital
Bath, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The East and North Hertfordshire NHS Trust
Middlesex, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield South Yorkshire, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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2013-000113-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABI-007-MBC-001
Identifier Type: -
Identifier Source: org_study_id
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