Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
6 other identifiers
interventional
652
21 countries
257
Brief Summary
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Oct 2008
Longer than P75 for phase_3 breast-cancer
257 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedStudy Start
First participant enrolled
October 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedResults Posted
Study results publicly available
June 18, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedMarch 21, 2025
March 1, 2025
3.8 years
April 25, 2008
September 24, 2013
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) at the Time of Primary Results
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
Secondary Outcomes (25)
Progression Free Survival (PFS) at the Time of Final Analysis
From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months
Overall Survival (OS) (IIT Population)
From date of randomization until date of death from any cause, assessed up approximately 165 months
Overall Survival (OS) (Central HER2+ Population)
From date of randomization until date of death from any cause, assessed up approximately 165 months
Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population)
From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population)
From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
- +20 more secondary outcomes
Study Arms (2)
Lapatinib
ACTIVE COMPARATORPlus taxane based chemotherapy
Trastuzumab
ACTIVE COMPARATORPlus taxane based chemotherapy.
Interventions
IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).
80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the breast.
- MBC (stage IV) at primary diagnosis or at relapse after curative intent therapy.
- Local or central laboratory confirmed HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
- + over expression by immunohistochemistry (IHC) (\>30% of invasive tumour cells);
- + or 3+ (in 30% or less neoplastic cells) overexpression by IHC analysis AND fluorescence or chromogenic in situ hybridization (FISH/CISH) test demonstrating HER2/neu gene amplification;
- HER2/neu gene amplification by FISH/CISH \[\>6 HER2/neu gene copies per nucleus, or a FISH/CISH ratio (HER2 gene copies to chromosome 17 signals) of \>=2.2\]
- Subjects must have had evidence of metastatic disease, but measurable disease was not mandatory. To be considered evaluable for overall response rate (CR and PR), subjects must have had at least 1 measurable lesion as follows:
- X-ray, physical exam \>=20 mm.
- Conventional computed tomography (CT) scan, magnetic resonance imaging (MRI) \>=20 mm.
- Spiral CT scan \>=10 mm.
You may not qualify if:
- Subjects with a history of other malignancies, except: adequately treated ductal carcinoma in-situ or lobular carcinoma in-situ, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor (non-breast) curatively treated with no evidence of disease for \>=5 years.
- Subjects who had received prior chemotherapy, immunotherapy, biologic therapy or HER2/neu targeted therapy for recurrent or MBC.
- Subjects receiving ongoing anti-cancer treatment or other investigational anti-cancer agents for breast cancer or subjects who had used an investigational drug within 30 days or 5 half-lives (if known), whichever was longer, preceding the date of randomization.
- Subjects with: CNS metastases (including leptomeningeal involvement), serious cardiac illness, peripheral neuropathy grade 2 or greater, subjects with gastrointestinal tract disease, subjects receiving CYP3A4 inhibitors or inducers, and subjects with history of allergic or hypersensitivity reactions to any study drug or their excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- NCIC Clinical Trials Groupcollaborator
Study Sites (257)
Novartis Investigative Site
Anchorage, Alaska, 99508, United States
Novartis Investigative Site
Tucson, Arizona, 85715, United States
Novartis Investigative Site
Hot Springs, Arkansas, 71913, United States
Novartis Investigative Site
Berkeley, California, 94704, United States
Novartis Investigative Site
Highland, California, 92346, United States
Novartis Investigative Site
Montebello, California, 90640, United States
Novartis Investigative Site
Colorado Springs, Colorado, 80907, United States
Novartis Investigative Site
Denver, Colorado, 80204, United States
Novartis Investigative Site
Greenwich, Connecticut, 06830, United States
Novartis Investigative Site
Southington, Connecticut, 06489, United States
Novartis Investigative Site
Stamford, Connecticut, 06902-3628, United States
Novartis Investigative Site
Trumbull, Connecticut, 06611, United States
Novartis Investigative Site
Waterbury, Connecticut, 06708, United States
Novartis Investigative Site
Kissimmee, Florida, 34741, United States
Novartis Investigative Site
Loxahatchee Groves, Florida, 33470, United States
Novartis Investigative Site
New Port Richey, Florida, 34655, United States
Novartis Investigative Site
Augusta, Georgia, 30901, United States
Novartis Investigative Site
Lawrenceville, Georgia, 30046, United States
Novartis Investigative Site
Savannah, Georgia, 31405, United States
Novartis Investigative Site
Post Falls, Idaho, 83854, United States
Novartis Investigative Site
Chicago, Illinois, 60657, United States
Novartis Investigative Site
Oak Lawn, Illinois, 60453, United States
Novartis Investigative Site
Evansville, Indiana, 47713, United States
Novartis Investigative Site
Goshen, Indiana, 46526, United States
Novartis Investigative Site
Indianapolis, Indiana, 46237, United States
Novartis Investigative Site
Munster, Indiana, 46321, United States
Novartis Investigative Site
New Albany, Indiana, 47150, United States
Novartis Investigative Site
Towson, Maryland, 21204, United States
Novartis Investigative Site
Wheaton, Maryland, 20902, United States
Novartis Investigative Site
Bozeman, Montana, 59715, United States
Novartis Investigative Site
Grand Island, Nebraska, 68803, United States
Novartis Investigative Site
Kearney, Nebraska, 68845, United States
Novartis Investigative Site
Kearney, Nebraska, 68847, United States
Novartis Investigative Site
Denville, New Jersey, 07834, United States
Novartis Investigative Site
Parsippany, New Jersey, 07054, United States
Novartis Investigative Site
Cooperstown, New York, 13326, United States
Novartis Investigative Site
Greensboro, North Carolina, 27403, United States
Novartis Investigative Site
Canton, Ohio, 44718, United States
Novartis Investigative Site
Wooster, Ohio, 44691, United States
Novartis Investigative Site
Portland, Oregon, 97227, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15212-4772, United States
Novartis Investigative Site
Columbia, South Carolina, 29210, United States
Novartis Investigative Site
Memphis, Tennessee, 38120, United States
Novartis Investigative Site
Chesapeake, Virginia, 23320, United States
Novartis Investigative Site
Salem, Virginia, 24153, United States
Novartis Investigative Site
Bellevue, Washington, 98004, United States
Novartis Investigative Site
Kirkland, Washington, 98034, United States
Novartis Investigative Site
Mount Vernon, Washington, 98273, United States
Novartis Investigative Site
Seattle, Washington, 98109, United States
Novartis Investigative Site
Sequim, Washington, 98382, United States
Novartis Investigative Site
Tacoma, Washington, 98405, United States
Novartis Investigative Site
Wenatchee, Washington, 98801, United States
Novartis Investigative Site
Milwaukee, Wisconsin, 53226, United States
Novartis Investigative Site
Capital Federal, Buenos Aires, C1405CUB, Argentina
Novartis Investigative Site
Capital Federal, Buenos Aires, C1426ANZ, Argentina
Novartis Investigative Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, B1920CMK, Argentina
Novartis Investigative Site
Cipolletti, Río Negro Province, R8324EMB, Argentina
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Viedma, Río Negro Province, R8500ACE, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000KZE, Argentina
Novartis Investigative Site
San Miguel de Tucumán, 4000, Argentina
Novartis Investigative Site
Santa Fe, 3000, Argentina
Novartis Investigative Site
Garran, Australian Capital Territory, 2606, Australia
Novartis Investigative Site
Liverpool, New South Wales, 2170, Australia
Novartis Investigative Site
North Sydney, New South Wales, 2060, Australia
Novartis Investigative Site
Tweed Heads, New South Wales, 2485, Australia
Novartis Investigative Site
Woolloongabba, Queensland, 4102, Australia
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
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Bedford Park, South Australia, 5042, Australia
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Kurralta Park, South Australia, 5037, Australia
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Hobart, Tasmania, 7000, Australia
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Box Hill, Victoria, 3128, Australia
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Fitzroy, Victoria, 3065, Australia
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Wodonga, Victoria, 3690, Australia
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Subiaco, Western Australia, 6008, Australia
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Ghent, 9000, Belgium
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Jette, 1090, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Victoria, British Columbia, V8R 6V5, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 5P9, Canada
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London, Ontario, N6A 4L6, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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St. Catharines, Ontario, L2R 7C6, Canada
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Thunder Bay, Ontario, P7B 6V4, Canada
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Charlottetown, Prince Edward Island, C1A 8T5, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Québec, Quebec, G1S 4L8, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
Novartis Investigative Site
Angers, 49033, France
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Bordeaux, 33075, France
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Bordeaux, 33077, France
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Caen, 14076, France
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Marseille, 13273, France
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Metz-Tessy, 74370, France
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Nantes, 44202, France
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Paris, 75014, France
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Strasbourg, 67085, France
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Heidelberg, Baden-Wurttemberg, 69115, Germany
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Stuttgart, Baden-Wurttemberg, 70190, Germany
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Coburg, Bavaria, 96450, Germany
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Eggenfelden, Bavaria, 84307, Germany
Novartis Investigative Site
Fürth, Bavaria, 90766, Germany
Novartis Investigative Site
Regensburg, Bavaria, 93049, Germany
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Rosenheim, Bavaria, 83022, Germany
Novartis Investigative Site
Weiden, Bavaria, 92637, Germany
Novartis Investigative Site
Fürstenwalde, Brandenburg, 15517, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 60596, Germany
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Fulda, Hesse, 36043, Germany
Novartis Investigative Site
Lich, Hesse, 35423, Germany
Novartis Investigative Site
Goslar, Lower Saxony, 38642, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30559, Germany
Novartis Investigative Site
Leer, Lower Saxony, 26789, Germany
Novartis Investigative Site
Bielefeld, North Rhine-Westphalia, 33611, Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia, 53113, Germany
Novartis Investigative Site
Coesfeld, North Rhine-Westphalia, 48653, Germany
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Cologne, North Rhine-Westphalia, 51067, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Porta Westfalica, North Rhine-Westphalia, 32457, Germany
Novartis Investigative Site
Troisdorf, North Rhine-Westphalia, 53840, Germany
Novartis Investigative Site
Velbert, North Rhine-Westphalia, 42551, Germany
Novartis Investigative Site
Witten, North Rhine-Westphalia, 58452, Germany
Novartis Investigative Site
Koblenz, Rhineland-Palatinate, 56068, Germany
Novartis Investigative Site
Saarbrücken, Saarland, 66113, Germany
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Dresden, Saxony, 01127, Germany
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120, Germany
Novartis Investigative Site
Lübeck, Schleswig-Holstein, 23538, Germany
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Berlin, 10367, Germany
Novartis Investigative Site
Brandenburg, 14770, Germany
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Hamburg, 20095, Germany
Novartis Investigative Site
Hamburg, 22081, Germany
Novartis Investigative Site
Hamburg, 22767, Germany
Novartis Investigative Site
Bangalore, 560038, India
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Nagpur, 440010, India
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Pune, 411001, India
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Beersheba, 84101, Israel
Novartis Investigative Site
Holon, 58100, Israel
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Petah Tikva, 49100, Israel
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Poria – Neve Oved, 15208, Israel
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Ramat Gan, 52621, Israel
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Lecce, Apulia, 73100, Italy
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Aviano (PN), Friuli Venezia Giulia, 33081, Italy
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Rome, Lazio, 00189, Italy
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Sora (FR), Lazio, 03039, Italy
Novartis Investigative Site
Genoa, Liguria, 16132, Italy
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Sassari, Sardinia, 07100, Italy
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Prato (PO), Tuscany, 59100, Italy
Novartis Investigative Site
Chieti, 66100, Italy
Novartis Investigative Site
Aichi, 464-8681, Japan
Novartis Investigative Site
Chiba, 277-8577, Japan
Novartis Investigative Site
Ehime, 791-0280, Japan
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Kagoshima, 892-0833, Japan
Novartis Investigative Site
Kanagawa, 241-8515, Japan
Novartis Investigative Site
Osaka, 540-0006, Japan
Novartis Investigative Site
Osaka, 565-0871, Japan
Novartis Investigative Site
Saitama, 350-1298, Japan
Novartis Investigative Site
Saitama, 362-0806, Japan
Novartis Investigative Site
Shizuoka, 411-8777, Japan
Novartis Investigative Site
Tokyo, 104-8560, Japan
Novartis Investigative Site
Tokyo, 113-8677, Japan
Novartis Investigative Site
Cuernavaca, Morelos, 62450, Mexico
Novartis Investigative Site
Ciudad Obregón, Sonora, 85000, Mexico
Novartis Investigative Site
Mexico City, CP 14080, Mexico
Novartis Investigative Site
Amsterdam, 1091 AC, Netherlands
Novartis Investigative Site
Delft, 2625 AD, Netherlands
Novartis Investigative Site
Dordrecht, 3318 AT, Netherlands
Novartis Investigative Site
Maastricht, 6229 HX, Netherlands
Novartis Investigative Site
Gdansk, 80-219, Poland
Novartis Investigative Site
Lodz, 93-509, Poland
Novartis Investigative Site
Olsztyn, 10-226, Poland
Novartis Investigative Site
Olsztyn, 10-513, Poland
Novartis Investigative Site
Płock, 09-400, Poland
Novartis Investigative Site
Rzeszów, 35-021, Poland
Novartis Investigative Site
Warsaw, 02-781, Poland
Novartis Investigative Site
Warsaw, 04-125, Poland
Novartis Investigative Site
Arkhangelsk, 163045, Russia
Novartis Investigative Site
Ivanovo, 153013, Russia
Novartis Investigative Site
Kazan', 420029, Russia
Novartis Investigative Site
Kirov, 610021, Russia
Novartis Investigative Site
Lipetsk, 398005, Russia
Novartis Investigative Site
Moscow, 115 478, Russia
Novartis Investigative Site
Ryazan, 390011, Russia
Novartis Investigative Site
Saint Petersburg, 197022, Russia
Novartis Investigative Site
Saint Petersburg, 197758, Russia
Novartis Investigative Site
Stavropol, 355047, Russia
Novartis Investigative Site
Ufa, 450054, Russia
Novartis Investigative Site
Gyeonggi-do, 10408, South Korea
Novartis Investigative Site
Gyeonggi-do, 410-769, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 110-744, South Korea
Novartis Investigative Site
Seoul, 120-752, South Korea
Novartis Investigative Site
Songpa-gu, Seoul, 138-736, South Korea
Novartis Investigative Site
A Coruña, 15009, Spain
Novartis Investigative Site
Alcorcón, 28922, Spain
Novartis Investigative Site
Alicante, 03010, Spain
Novartis Investigative Site
Badalona, 08916, Spain
Novartis Investigative Site
Barcelona, 08036, Spain
Novartis Investigative Site
Elche, 03202, Spain
Novartis Investigative Site
Girona, 17007, Spain
Novartis Investigative Site
Jaén, 23007, Spain
Novartis Investigative Site
Lugo, 27003, Spain
Novartis Investigative Site
Madrid, 28007, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Majadahonda (Madrid), 28222, Spain
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Pozuelo de Alarcon (Madrid), 28223, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Changhua, 500, Taiwan
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Taichung, 404, Taiwan
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Tainan County, 736, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dnipro, 49102, Ukraine
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Dnipropetrovsk, 49100, Ukraine
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Lviv, 79031, Ukraine
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Sumy, 40005, Ukraine
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Bournemouth, BH7 7DW, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Chelmsford, CM1 7ET, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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Colchester, CO3 3NB, United Kingdom
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Cottingham, Hull, HU16 5JQ, United Kingdom
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Derby, DE22 3NE, United Kingdom
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Edmonton, N18 1QX, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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Harrogate, HG2 7SX, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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London, SW3 6JJ, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
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Poole, Dorset, BH15 2JB, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Shrewsbury, SY3 8XQ, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Whitchurch, Cardiff, CF14 2TL, United Kingdom
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York, YO31 8HE, United Kingdom
Related Publications (3)
Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol. 2015 May 10;33(14):1574-83. doi: 10.1200/JCO.2014.56.9590. Epub 2015 Mar 16.
PMID: 25779558RESULTHo D, Huang J, Chapman JW, Leitzel K, Ali SM, Shepherd L, Parulekar WR, Ellis CE, Crescnzo RJ, Zhu L, Virk S, Nomikos D, Aparicio S, Gelmon KA, Carney WP, Lipton A. Impact of serum HER2, TIMP-1, and CAIX on outcome for HER2+ metastatic breast cancer patients: CCTG MA.31 (lapatinib vs. trastuzumab). Breast Cancer Res Treat. 2017 Aug;164(3):571-580. doi: 10.1007/s10549-017-4273-x. Epub 2017 May 8.
PMID: 28484925RESULTLiu S, Chen B, Burugu S, Leung S, Gao D, Virk S, Kos Z, Parulekar WR, Shepherd L, Gelmon KA, Nielsen TO. Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 Nov 9;3(11):e172085. doi: 10.1001/jamaoncol.2017.2085. Epub 2017 Nov 9.
PMID: 28750133RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 28, 2008
Study Start
October 7, 2008
Primary Completion
August 1, 2012
Study Completion
July 27, 2022
Last Updated
March 21, 2025
Results First Posted
June 18, 2014
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com