Clinical trial NCT01881230: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Tumor
Breast Cancer
Cancer of the Breast
Estrogen Receptor- Negative Breast Cancer
HER2- Negative Breast Cancer
Progesterone Receptor- Negative Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Triple-negative Breast Cancer
Triple-negative Metastatic Breast Cancer
Metastatic Breast Cancer
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
Phase 3
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 cancer.

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.

Eligibility criteria: Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria are met:

1. Female subjects, age ≥ 18 years at the time informed consent is signed
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:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

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

Primary outcomes:
measure: Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
timeFrame: 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:
measure: Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
timeFrame: 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
measure: Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy
timeFrame: Cycle 6
measure: Kaplan-Meier Estimates of Overall Survival
timeFrame: 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
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 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
measure: Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)
timeFrame: 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
measure: Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs
timeFrame: 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
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Glendale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Cancer Research Alliance
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc
state: California
city: Escondido
country: United States
facility: California Cancer Associates for Research and Excellence cCARE
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc
state: California
city: Los Angeles
country: United States
facility: Translational Research Management
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group, INC
state: California
city: Boca Raton
country: United States
facility: Center for Hematology-Oncology
state: Florida
city: Hollywood
country: United States
facility: Memorial Breast Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Lafayette
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Med
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, PC
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Midwest Physicians Group
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Hooksett
country: United States
facility: New Hampshire Oncology Hematology
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of CNY
state: New York
city: Lake Success
country: United States
facility: NYU Langone Arena Oncology
state: New York
city: New York
country: United States
facility: Clinical Research Alliance
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnatti
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Columbus
country: United States
facility: Mark H Zangmeister Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Community Oncology Program
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma
state: Oklahoma
city: Coos Bay
country: United States
facility: North Bend Medical Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C. - Hoyt
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Langhorne
country: United States
facility: St Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA- Dallas
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: UT Physicians General Medicine
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas - Loop
state: Texas
city: Tyler
country: United States
facility: Texas Oncology P.A.- Tyler
state: Texas
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Portsmouth
country: United States
facility: Delta Hematologyoncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St Marys Cancer Center
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Frankston
country: Australia
facility: Frankston Hospital Oncology Research
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Innsbruck
country: Austria
facility: Universitaetsklinik Innsbruck
city: Salzburg
country: Austria
facility: Salzburger Landkliniken St. Johanns-Spital
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Salvador
country: Brazil
facility: Centro de Oncologia Da Bahia
state: Bahia
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer
state: Paraná
city: Rio De Janerio
country: Brazil
facility: Instituto Nacional de Cancer - INCA
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: São Paulo
city: Jau/SP
country: Brazil
facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
state: São Paulo
city: Fortaleza
country: Brazil
facility: ONCOCLINIC Clinica de Oncologia LTDA
city: Ribeirao Preto
country: Brazil
facility: Instituto Ribeiraopretano de Combate Ao Cancer
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da USP
city: Rio Grande Do Sul
country: Brazil
facility: Hospital Bruno Born
city: Sao Jose Do Rio Preto
country: Brazil
facility: Hospital de Base Da Faculdade de Medicina de
city: Sao Paulo
country: Brazil
facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle Do Cancer IBCC
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Notre Dame
state: Quebec
city: Quebec City
country: Canada
facility: Hospital du Saint Scarement Sacrement Laboratory
state: Quebec
city: Rimouski
country: Canada
facility: CSSS de Rimouski Neigette
state: Quebec
city: Regina
country: Canada
facility: Alan Blair Cancer Centre at Pasqua Hosptial
state: Saskatchewan
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus
city: Bonn
country: Germany
facility: Facharztpraxis fur Gynakologie und Geburtshilfe
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Freiburg
country: Germany
facility: Praxis fur interdisziplinare Onkologie & Hamatologie
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Hildesheim
country: Germany
facility: Frauenarzte am Bahnhofsplatz
city: Köln
country: Germany
facility: Schwerpunktpraxis fur Gynakologische Onkologie
city: München
country: Germany
facility: LMU Klinikum der Universitat
city: Trier
country: Germany
facility: Krankenanstalt Mutterhaus der Borromaerinnen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Athens
country: Greece
facility: University of Athens Medical school - Regional General Hospital
city: Athens
country: Greece
facility: IASO General
city: Faliro
country: Greece
facility: Metropolitan Hospital
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Rio Patras
country: Greece
facility: University General Hospital of Patras
city: Bologna, Emilia-Romagna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna
city: Genova
country: Italy
facility: IRCCS AziendaOspedaliera Universitaria San Martino
city: Grosseto
country: Italy
facility: Presidio Ospedaliero della Misericordia
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Napoli, Campania
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli, Campania
country: Italy
facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Policlinico Universitario A Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant Andrea
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Torino, Piemonte
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Treviglio-Caravaggio
city: Evora
country: Portugal
facility: Hospital Espirito Santo
city: Lisboa
country: Portugal
facility: Hospital Da Luz
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil
city: Barcelona
country: Spain
facility: Clinic Barcelona Hospital Universitari
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D Hebron
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital General Gregorio Maranon
city: San Sebastian
country: Spain
facility: Onkologikoa - Kutxaren Institutu Onkologikoa
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Middlesex
country: United Kingdom
facility: The East and North Hertfordshire NHS Trust
city: Sheffield South Yorkshire
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Celgene Corporation
name: Ileana Elias, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.