Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

NCT ID: NCT00667251

Last Updated: 2025-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-07

Study Completion Date

2022-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects were stratified by

* Prior (neo) adjuvant HER2/neu targeted therapy (yes, no)
* Prior (neo) adjuvant taxane chemotherapy (yes, no)
* Planned taxane treatment (once weekly paclitaxel versus docetaxel once every 3 weeks)
* Liver metastasis (yes, no)

Subjects were randomized 1:1 to the following treatments to a planned sample size of approximately 600 subjects (to achieve 536 centrally confirmed HER2 positive subjects):

* Taxane based chemotherapy plus lapatinib for 24 weeks followed by single agent lapatinib
* Taxane based chemotherapy plus trastuzumab for 24 weeks followed by single agent trastuzumab

The choice of taxane (once weekly paclitaxel versus docetaxel once every 3 weeks) was at the discretion of the treating physician and was specified at the time of subject randomization.

A protocol-specified interim analysis was conducted on 27-Apr-2012, following which the participants in the Lapatinib plus taxane based chemotherapy arm could cross over to Taxane based chemotherapy plus Trastuzumab.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lapatinib

Plus taxane based chemotherapy

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

lapatinib ditosylate

Intervention Type DRUG

1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).

paclitaxel

Intervention Type DRUG

80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Trastuzumab

Plus taxane based chemotherapy.

Group Type ACTIVE_COMPARATOR

trastuzumab

Intervention Type BIOLOGICAL

IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).

docetaxel

Intervention Type DRUG

75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

paclitaxel

Intervention Type DRUG

80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trastuzumab

IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).

Intervention Type BIOLOGICAL

docetaxel

75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

Intervention Type DRUG

lapatinib ditosylate

1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).

Intervention Type DRUG

paclitaxel

80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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:

1. 3+ over expression by immunohistochemistry (IHC) (\>30% of invasive tumour cells);
2. 2+ 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;
3. 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:

1. X-ray, physical exam \>=20 mm.
2. Conventional computed tomography (CT) scan, magnetic resonance imaging (MRI) \>=20 mm.
3. Spiral CT scan \>=10 mm.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Anchorage, Alaska, United States

Site Status

Novartis Investigative Site

Tucson, Arizona, United States

Site Status

Novartis Investigative Site

Hot Springs, Arkansas, United States

Site Status

Novartis Investigative Site

Berkeley, California, United States

Site Status

Novartis Investigative Site

Highland, California, United States

Site Status

Novartis Investigative Site

Montebello, California, United States

Site Status

Novartis Investigative Site

Colorado Springs, Colorado, United States

Site Status

Novartis Investigative Site

Denver, Colorado, United States

Site Status

Novartis Investigative Site

Greenwich, Connecticut, United States

Site Status

Novartis Investigative Site

Southington, Connecticut, United States

Site Status

Novartis Investigative Site

Stamford, Connecticut, United States

Site Status

Novartis Investigative Site

Trumbull, Connecticut, United States

Site Status

Novartis Investigative Site

Waterbury, Connecticut, United States

Site Status

Novartis Investigative Site

Kissimmee, Florida, United States

Site Status

Novartis Investigative Site

Loxahatchee Groves, Florida, United States

Site Status

Novartis Investigative Site

New Port Richey, Florida, United States

Site Status

Novartis Investigative Site

Augusta, Georgia, United States

Site Status

Novartis Investigative Site

Lawrenceville, Georgia, United States

Site Status

Novartis Investigative Site

Savannah, Georgia, United States

Site Status

Novartis Investigative Site

Post Falls, Idaho, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Oak Lawn, Illinois, United States

Site Status

Novartis Investigative Site

Evansville, Indiana, United States

Site Status

Novartis Investigative Site

Goshen, Indiana, United States

Site Status

Novartis Investigative Site

Munster, Indiana, United States

Site Status

Novartis Investigative Site

New Albany, Indiana, United States

Site Status

Novartis Investigative Site

Towson, Maryland, United States

Site Status

Novartis Investigative Site

Wheaton, Maryland, United States

Site Status

Novartis Investigative Site

Bozeman, Montana, United States

Site Status

Novartis Investigative Site

Grand Island, Nebraska, United States

Site Status

Novartis Investigative Site

Kearney, Nebraska, United States

Site Status

Novartis Investigative Site

Kearney, Nebraska, United States

Site Status

Novartis Investigative Site

Denville, New Jersey, United States

Site Status

Novartis Investigative Site

Parsippany, New Jersey, United States

Site Status

Novartis Investigative Site

Cooperstown, New York, United States

Site Status

Novartis Investigative Site

Greensboro, North Carolina, United States

Site Status

Novartis Investigative Site

Canton, Ohio, United States

Site Status

Novartis Investigative Site

Wooster, Ohio, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis Investigative Site

Columbia, South Carolina, United States

Site Status

Novartis Investigative Site

Memphis, Tennessee, United States

Site Status

Novartis Investigative Site

Chesapeake, Virginia, United States

Site Status

Novartis Investigative Site

Salem, Virginia, United States

Site Status

Novartis Investigative Site

Bellevue, Washington, United States

Site Status

Novartis Investigative Site

Kirkland, Washington, United States

Site Status

Novartis Investigative Site

Mount Vernon, Washington, United States

Site Status

Novartis Investigative Site

Seattle, Washington, United States

Site Status

Novartis Investigative Site

Sequim, Washington, United States

Site Status

Novartis Investigative Site

Tacoma, Washington, United States

Site Status

Novartis Investigative Site

Wenatchee, Washington, United States

Site Status

Novartis Investigative Site

Milwaukee, Wisconsin, United States

Site Status

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Cipolletti, Río Negro Province, Argentina

Site Status

Novartis Investigative Site

Viedma, Río Negro Province, Argentina

Site Status

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Site Status

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Site Status

Novartis Investigative Site

Santa Fe, , Argentina

Site Status

Novartis Investigative Site

Garran, Australian Capital Territory, Australia

Site Status

Novartis Investigative Site

Liverpool, New South Wales, Australia

Site Status

Novartis Investigative Site

North Sydney, New South Wales, Australia

Site Status

Novartis Investigative Site

Tweed Heads, New South Wales, Australia

Site Status

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Site Status

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status

Novartis Investigative Site

Bedford Park, South Australia, Australia

Site Status

Novartis Investigative Site

Kurralta Park, South Australia, Australia

Site Status

Novartis Investigative Site

Hobart, Tasmania, Australia

Site Status

Novartis Investigative Site

Box Hill, Victoria, Australia

Site Status

Novartis Investigative Site

Fitzroy, Victoria, Australia

Site Status

Novartis Investigative Site

Wodonga, Victoria, Australia

Site Status

Novartis Investigative Site

Subiaco, Western Australia, Australia

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Jette, , Belgium

Site Status

Novartis Investigative Site

Liège, , Belgium

Site Status

Novartis Investigative Site

Namur, , Belgium

Site Status

Novartis Investigative Site

Edmonton, Alberta, Canada

Site Status

Novartis Investigative Site

Kelowna, British Columbia, Canada

Site Status

Novartis Investigative Site

Surrey, British Columbia, Canada

Site Status

Novartis Investigative Site

Vancouver, British Columbia, Canada

Site Status

Novartis Investigative Site

Victoria, British Columbia, Canada

Site Status

Novartis Investigative Site

Winnipeg, Manitoba, Canada

Site Status

Novartis Investigative Site

Moncton, New Brunswick, Canada

Site Status

Novartis Investigative Site

Saint John, New Brunswick, Canada

Site Status

Novartis Investigative Site

Barrie, Ontario, Canada

Site Status

Novartis Investigative Site

Greater Sudbury, Ontario, Canada

Site Status

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status

Novartis Investigative Site

Kingston, Ontario, Canada

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Newmarket, Ontario, Canada

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Novartis Investigative Site

Sault Ste. Marie, Ontario, Canada

Site Status

Novartis Investigative Site

St. Catharines, Ontario, Canada

Site Status

Novartis Investigative Site

Thunder Bay, Ontario, Canada

Site Status

Novartis Investigative Site

Charlottetown, Prince Edward Island, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Regina, Saskatchewan, Canada

Site Status

Novartis Investigative Site

Saskatoon, Saskatchewan, Canada

Site Status

Novartis Investigative Site

Angers, , France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Caen, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Metz-Tessy, , France

Site Status

Novartis Investigative Site

Nantes, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Coburg, Bavaria, Germany

Site Status

Novartis Investigative Site

Eggenfelden, Bavaria, Germany

Site Status

Novartis Investigative Site

Fürth, Bavaria, Germany

Site Status

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status

Novartis Investigative Site

Rosenheim, Bavaria, Germany

Site Status

Novartis Investigative Site

Weiden, Bavaria, Germany

Site Status

Novartis Investigative Site

Fürstenwalde, Brandenburg, Germany

Site Status

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status

Novartis Investigative Site

Fulda, Hesse, Germany

Site Status

Novartis Investigative Site

Lich, Hesse, Germany

Site Status

Novartis Investigative Site

Goslar, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Hanover, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Leer, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Bielefeld, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Bonn, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Coesfeld, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Essen, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Porta Westfalica, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Troisdorf, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Velbert, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Witten, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Koblenz, Rhineland-Palatinate, Germany

Site Status

Novartis Investigative Site

Saarbrücken, Saarland, Germany

Site Status

Novartis Investigative Site

Dresden, Saxony, Germany

Site Status

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Site Status

Novartis Investigative Site

Lübeck, Schleswig-Holstein, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Brandenburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Bangalore, , India

Site Status

Novartis Investigative Site

Nagpur, , India

Site Status

Novartis Investigative Site

Pune, , India

Site Status

Novartis Investigative Site

Beersheba, , Israel

Site Status

Novartis Investigative Site

Holon, , Israel

Site Status

Novartis Investigative Site

Petah Tikva, , Israel

Site Status

Novartis Investigative Site

Poria – Neve Oved, , Israel

Site Status

Novartis Investigative Site

Ramat Gan, , Israel

Site Status

Novartis Investigative Site

Lecce, Apulia, Italy

Site Status

Novartis Investigative Site

Aviano (PN), Friuli Venezia Giulia, Italy

Site Status

Novartis Investigative Site

Rome, Lazio, Italy

Site Status

Novartis Investigative Site

Sora (FR), Lazio, Italy

Site Status

Novartis Investigative Site

Genoa, Liguria, Italy

Site Status

Novartis Investigative Site

Sassari, Sardinia, Italy

Site Status

Novartis Investigative Site

Prato (PO), Tuscany, Italy

Site Status

Novartis Investigative Site

Chieti, , Italy

Site Status

Novartis Investigative Site

Aichi, , Japan

Site Status

Novartis Investigative Site

Chiba, , Japan

Site Status

Novartis Investigative Site

Ehime, , Japan

Site Status

Novartis Investigative Site

Kagoshima, , Japan

Site Status

Novartis Investigative Site

Kanagawa, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Saitama, , Japan

Site Status

Novartis Investigative Site

Saitama, , Japan

Site Status

Novartis Investigative Site

Shizuoka, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Cuernavaca, Morelos, Mexico

Site Status

Novartis Investigative Site

Ciudad Obregón, Sonora, Mexico

Site Status

Novartis Investigative Site

Mexico City, , Mexico

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Delft, , Netherlands

Site Status

Novartis Investigative Site

Dordrecht, , Netherlands

Site Status

Novartis Investigative Site

Maastricht, , Netherlands

Site Status

Novartis Investigative Site

Gdansk, , Poland

Site Status

Novartis Investigative Site

Lodz, , Poland

Site Status

Novartis Investigative Site

Olsztyn, , Poland

Site Status

Novartis Investigative Site

Olsztyn, , Poland

Site Status

Novartis Investigative Site

Płock, , Poland

Site Status

Novartis Investigative Site

Rzeszów, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Arkhangelsk, , Russia

Site Status

Novartis Investigative Site

Ivanovo, , Russia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Kirov, , Russia

Site Status

Novartis Investigative Site

Lipetsk, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Ryazan, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Stavropol, , Russia

Site Status

Novartis Investigative Site

Ufa, , Russia

Site Status

Novartis Investigative Site

Gyeonggi-do, , South Korea

Site Status

Novartis Investigative Site

Gyeonggi-do, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Songpa-gu, Seoul, , South Korea

Site Status

Novartis Investigative Site

A Coruña, , Spain

Site Status

Novartis Investigative Site

Alcorcón, , Spain

Site Status

Novartis Investigative Site

Alicante, , Spain

Site Status

Novartis Investigative Site

Badalona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Elche, , Spain

Site Status

Novartis Investigative Site

Girona, , Spain

Site Status

Novartis Investigative Site

Jaén, , Spain

Site Status

Novartis Investigative Site

Lugo, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Majadahonda (Madrid), , Spain

Site Status

Novartis Investigative Site

Pozuelo de Alarcon (Madrid), , Spain

Site Status

Novartis Investigative Site

Seville, , Spain

Site Status

Novartis Investigative Site

Valencia, , Spain

Site Status

Novartis Investigative Site

Changhua, , Taiwan

Site Status

Novartis Investigative Site

Taichung, , Taiwan

Site Status

Novartis Investigative Site

Tainan County, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Chiang Mai, , Thailand

Site Status

Novartis Investigative Site

Dnipro, , Ukraine

Site Status

Novartis Investigative Site

Dnipropetrovsk, , Ukraine

Site Status

Novartis Investigative Site

Lviv, , Ukraine

Site Status

Novartis Investigative Site

Sumy, , Ukraine

Site Status

Novartis Investigative Site

Bournemouth, , United Kingdom

Site Status

Novartis Investigative Site

Brighton, , United Kingdom

Site Status

Novartis Investigative Site

Chelmsford, , United Kingdom

Site Status

Novartis Investigative Site

Cheltenham, , United Kingdom

Site Status

Novartis Investigative Site

Colchester, , United Kingdom

Site Status

Novartis Investigative Site

Cottingham, Hull, , United Kingdom

Site Status

Novartis Investigative Site

Derby, , United Kingdom

Site Status

Novartis Investigative Site

Edmonton, , United Kingdom

Site Status

Novartis Investigative Site

Guildford, , United Kingdom

Site Status

Novartis Investigative Site

Harrogate, , United Kingdom

Site Status

Novartis Investigative Site

Huddersfield, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Site Status

Novartis Investigative Site

Norwich, , United Kingdom

Site Status

Novartis Investigative Site

Nottingham, , United Kingdom

Site Status

Novartis Investigative Site

Oxford, , United Kingdom

Site Status

Novartis Investigative Site

Poole, Dorset, , United Kingdom

Site Status

Novartis Investigative Site

Sheffield, , United Kingdom

Site Status

Novartis Investigative Site

Shrewsbury, , United Kingdom

Site Status

Novartis Investigative Site

Sutton, , United Kingdom

Site Status

Novartis Investigative Site

Whitchurch, Cardiff, , United Kingdom

Site Status

Novartis Investigative Site

York, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Canada France Germany India Israel Italy Japan Mexico Netherlands Poland Russia South Korea Spain Taiwan Thailand Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25779558 (View on PubMed)

Ho 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.

Reference Type RESULT
PMID: 28484925 (View on PubMed)

Liu 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.

Reference Type RESULT
PMID: 28750133 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLAP016A2303

Identifier Type: OTHER

Identifier Source: secondary_id

CAN-NCIC-MA31

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007-004568-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000594764

Identifier Type: OTHER

Identifier Source: secondary_id

EGF108919

Identifier Type: OTHER

Identifier Source: secondary_id

108919

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.