Clinical trial NCT00667251: Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: recurrent breast cancer
HER2-positive breast cancer
stage IV breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: NCIC Clinical Trials Group
First posted: 2008-04-28
Enrollment: 652
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: 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: 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.

Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Progression Free Survival (PFS) at the Time of Primary Results
timeFrame: 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:
measure: Progression Free Survival (PFS) at the Time of Final Analysis
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months
measure: Overall Survival (OS) (IIT Population)
timeFrame: From date of randomization until date of death from any cause, assessed up approximately 165 months
measure: Overall Survival (OS) (Central HER2+ Population)
timeFrame: From date of randomization until date of death from any cause, assessed up approximately 165 months
measure: Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population)
timeFrame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
measure: Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population)
timeFrame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
measure: Time to Central Nervous System (CNS) Metastasis (IIT Population)
timeFrame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
measure: Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population)
timeFrame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
measure: Overall Response Rate (ORR) (IIT Population)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
measure: Overall Response Rate (ORR) (Central HER2+ Population)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
measure: Clinical Benefit Response (CBR) (IIT Population)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
measure: Clinical Benefit Response (CBR) (Central HER2+ Population)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
measure: Time to Response (TTR) (IIT Population)
timeFrame: From date of randomization until date of first response, assessed up approximately 45 months
measure: Time to Response (TTR) (Central HER2+ Population)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
measure: Duration of Response (DoR) (IIT Population)
timeFrame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months
measure: Duration of Response (DoR) (Central HER2+ Population)
timeFrame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months
measure: EORTC QLQ-C30 Global Score at 12 Weeks
timeFrame: Week 12
measure: Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only)
timeFrame: Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144
measure: Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144
measure: Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Number of Participant Hospitalized (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Total and Average Duration of Hospitalization (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Reasons for Hospitalization (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Type of Ward (Hospital Unit) (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Discharge Destinations (Canadian and Australian Centers Only)
timeFrame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
measure: Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status
timeFrame: Up to approximately 39 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Novartis Investigative Site
state: Alaska
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Hot Springs
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Berkeley
country: United States
facility: Novartis Investigative Site
state: California
city: Highland
country: United States
facility: Novartis Investigative Site
state: California
city: Montebello
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Greenwich
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Southington
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Stamford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Trumbull
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Kissimmee
country: United States
facility: Novartis Investigative Site
state: Florida
city: Loxahatchee Groves
country: United States
facility: Novartis Investigative Site
state: Florida
city: New Port Richey
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Lawrenceville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Post Falls
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Oak Lawn
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Evansville
country: United States
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state: Indiana
city: Goshen
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facility: Novartis Investigative Site
state: Indiana
city: Indianapolis
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city: Munster
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facility: Novartis Investigative Site
state: Indiana
city: New Albany
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state: Indiana
city: Towson
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state: Maryland
city: Wheaton
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facility: Novartis Investigative Site
state: Maryland
city: Bozeman
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facility: Novartis Investigative Site
state: Montana
city: Grand Island
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state: Nebraska
city: Kearney
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facility: Novartis Investigative Site
state: Nebraska
city: Kearney
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Denville
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facility: Novartis Investigative Site
state: New Jersey
city: Parsippany
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facility: Novartis Investigative Site
state: New Jersey
city: Cooperstown
country: United States
facility: Novartis Investigative Site
state: New York
city: Greensboro
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facility: Novartis Investigative Site
state: North Carolina
city: Canton
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state: Ohio
city: Wooster
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facility: Novartis Investigative Site
state: Ohio
city: Portland
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facility: Novartis Investigative Site
state: Oregon
city: Pittsburgh
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facility: Novartis Investigative Site
state: Pennsylvania
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Memphis
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facility: Novartis Investigative Site
state: Tennessee
city: Chesapeake
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facility: Novartis Investigative Site
state: Virginia
city: Salem
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Washington
city: Kirkland
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facility: Novartis Investigative Site
state: Washington
city: Mount Vernon
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Sequim
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Wenatchee
country: United States
facility: Novartis Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Cipolletti
country: Argentina
facility: Novartis Investigative Site
state: Río Negro
city: Viedma
country: Argentina
facility: Novartis Investigative Site
state: Río Negro
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Tucuman
country: Argentina
facility: Novartis Investigative Site
city: Garran
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: North Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Kurralta Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Wodonga
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Subiaco
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Namur
country: Belgium
facility: Novartis Investigative Site
city: Edmonton
country: Canada
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state: Alberta
city: Kelowna
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Saint John
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kingston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: St Catharines
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Charlottetown
country: Canada
facility: Novartis Investigative Site
state: Prince Edward Island
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen Cedex 05
country: France
facility: Novartis Investigative Site
city: Marseille cedex 9
country: France
facility: Novartis Investigative Site
city: Metz-Tessy
country: France
facility: Novartis Investigative Site
city: Nantes cedex
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Coburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Eggenfelden
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Fuerth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Rosenheim
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Weiden
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Fuerstenwalde
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Fulda
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Lich
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Goslar
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Leer
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Coesfeld
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Halle
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Brandenburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Bangalore
country: India
facility: Novartis Investigative Site
city: Nagpur
country: India
facility: Novartis Investigative Site
city: Pune
country: India
facility: Novartis Investigative Site
city: Beer-Sheva
country: Israel
facility: Novartis Investigative Site
city: Holon
country: Israel
facility: Novartis Investigative Site
city: Petah-Tikva
country: Israel
facility: Novartis Investigative Site
city: Poriya
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Aviano (pn)
country: Italy
facility: Novartis Investigative Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Sora (FR)
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Genova
country: Italy
facility: Novartis Investigative Site
state: Liguria
city: Lecce
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: Sardegna
city: Prato (PO)
country: Italy
facility: Novartis Investigative Site
state: Toscana
city: Chieti
country: Italy
facility: Novartis Investigative Site
city: Aichi
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Ehime
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kanagawa
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Songpa-gu, Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Cuernavaca
country: Mexico
facility: Novartis Investigative Site
state: Morelos
city: Ciudad Obregon
country: Mexico
facility: Novartis Investigative Site
state: Sonora
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Delft
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Plock
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kirov
country: Russian Federation
facility: Novartis Investigative Site
city: Lipetsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Stavropol
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa,
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Alcorcon
country: Spain
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Badalona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
city: Girona
country: Spain
facility: Novartis Investigative Site
city: Jaen
country: Spain
facility: Novartis Investigative Site
city: La Coruna
country: Spain
facility: Novartis Investigative Site
city: Lugo
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Majadahonda (Madrid)
country: Spain
facility: Novartis Investigative Site
city: Pozuelo De Alarcon (Madrid)
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan County
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiangmai
country: Thailand
facility: Novartis Investigative Site
city: Dnepropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Lviv
country: Ukraine
facility: Novartis Investigative Site
city: Sumy
country: Ukraine
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Brighton
country: United Kingdom
facility: Novartis Investigative Site
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
city: Cheltenham
country: United Kingdom
facility: Novartis Investigative Site
city: Colchester
country: United Kingdom
facility: Novartis Investigative Site
city: Cottingham, Hull
country: United Kingdom
facility: Novartis Investigative Site
city: Derby
country: United Kingdom
facility: Novartis Investigative Site
city: Edmonton
country: United Kingdom
facility: Novartis Investigative Site
city: Guildford
country: United Kingdom
facility: Novartis Investigative Site
city: Harrogate
country: United Kingdom
facility: Novartis Investigative Site
city: Huddersfield
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Norwich
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Poole, Dorset
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
city: Whitchurch, Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.