LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125566
Recruitment Status : Active, not recruiting
First Posted : May 18, 2010
Results First Posted : August 21, 2014
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: BIBW 2992 Drug: trastuzumab Drug: vinorelbine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment
Actual Study Start Date : June 22, 2010
Actual Primary Completion Date : June 8, 2013
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm B: trastuzumab with vinorelbine
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
Drug: trastuzumab
patients receive trastuzumab 2mg/kg intravenously every week
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week
Experimental: Arm A: BIBW 2992 with vinorelbine
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
Drug: BIBW 2992
patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week

Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: From randomization until disease progression, death or data cut-off (08Jun2013); Up to 34 months ]

    PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

    Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.

    Progression of disease was determined if at least 1 of the following criteria applied:

    • At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
    • Appearance of 1 or more new lesions
    • Unequivocal progression of existing non-target lesions

Secondary Outcome Measures :
  1. Objective Response (OR) [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months) ]

    OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to RECIST 1.1.

    Only data collected until the cut-off date 08Jun2013 were considered. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.

    Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Other factors which add to the overall response of an imaging timepoint as PR are as below:-

    • CR in TL, but non-CR/Non-PD in NTL leads to PR
    • CR in TL, but not evaluated NTL leads to PR
    • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR

  2. Best RECIST Assessment [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months) ]

    Best RECIST assessment is defined as CR, PR, stable disease (SD), PD or not evaluable by investigator (RECIST version 1.1).

    CR for target lesions (TL): Disappearance of all target lesions.

    CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).

    PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.

    PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.

  3. Overall Survival (OS) [ Time Frame: From randomisation to data cut-off (03Sep2013); Up to 37 months. ]

    OS is defined as time from randomisation to death irrespective of the cause of the death.

    For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histologically confirmed diagnosis of HER2-overexpression breast cancer
  • Stage IV metastatic disease
  • Must have progressed on one prior trastuzumab treatment
  • no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
  • Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
  • Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
  • At least one measurable lesion according to RECIST 1.1.
  • ECOG score of 0 or 1 .

Exclusion criteria:

  • Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab
  • Prior treatment with vinorelbine
  • Known pre-existing interstitial lung disease
  • Active brain metastases
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
  • Cardiac left ventricular function with resting ejection fraction of less than 50%.
  • Patients unable to comply with the protocol.
  • Any contraindications for therapy with vinorelbine or trastuzumab.
  • Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
  • Use of any investigational drug within 4 weeks of randomisation.
  • Inadequate hepatic, renal and haematologic organ function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01125566

  Hide Study Locations
United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
United States, California
Robert A. Moss MD, FACP, Inc
Fountain Valley, California, United States, 92708
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
University of California
Los Angeles, California, United States, 90095
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States, 90277
Santa Barbara Hematology Oncology Medical Group, Inc
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Illinois
North Shore Cancer Research Associates
Skokie, Illinois, United States, 60076
United States, Iowa
Cedar Valley Cancer Center
Waterloo, Iowa, United States, 50701
United States, New York
Pro Health Care Associated
Lake Success, New York, United States, 11042
United States, North Carolina
Hope Women's Cancer Center
Asheville, North Carolina, United States, 28806
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Utah
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States, 84106
Instituto Medico de Asistencia e Investigaciones S. A.
Buenos Aires, Argentina, C1425AWC
Hospital Britanico
Capital Federal, Argentina, C1280AEB
Sanatorio de la Provodencia
Ciudad Autonoma de Bs As, Argentina, C1050AAK
Sanatorio Parque
Rosario, Argentina, S2000DSK
Australia, New South Wales
Port Macquarie Base Hospital (PMBH)
Port Macquarie, New South Wales, Australia, 2444
Australia, Victoria
St. Vincents Hospital (MEL)
Fitzroy, Victoria, Australia, 3065
Peninsula Oncology Centre
Frankston, Victoria, Australia, 3199
Maroondah Hospital
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
Mount Medical Centre
Perth, Western Australia, Australia, 6000
KH d. Elisabethinen Linz
Linz, Austria, 4020
Kaiser Franz Josef Spital Vienna
Wien, Austria, 1100
Grodno Regional Clinical Hospital
Grodno, Belarus, 230017
N. N. Alexandrov National Cancer Center of Belarus
Minsk Region, Belarus, 223040
Public Health Inst. Minsk City Clinical Oncology Dispensary
Minsk, Belarus, 220013
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, Belarus, 210603
Brussels - HOSP Jules Bordet
Bruxelles, Belgium, 1000
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Liège - HOSP St-Joseph
Liège, Belgium, 4000
Centro de Pesquisas Clínicas em Oncología
Cachoeiro de Itapemirim, Brazil, 29308-014
Hospital Santa Cruz
Curitiba, Brazil, 80420-090
Associacao Hospital de Caridade de Ijui
Ijui, Brazil, 98700-000
Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Centro de Novos Tratamentos CliniOnco
Porto Alegre, Brazil, 90430-090
Instituto Nacional do Câncer - INCA
Rio de Janeiro, Brazil, 20560-120
Faculdade de Medicina do ABC
Santo André, Brazil, 09060-650
Centro de Referência da Saude da Mulher-Hosp Perola Byington
Sao Paulo, Brazil, 01317-000
Canada, British Columbia
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Migration Data
Hopital Notre-Dame du CHUM
Montreal, Migration Data, Canada, H2L 4M1
Hop. Du St. Sacrement
Quebec, Migration Data, Canada, G1S 4L8
Canada, New Brunswick
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Instituto Clínico Oncológico del Sur - ICOS
Temuco, Chile
Cancer Hospital of Chinese Academy of Medical Science
Beijing, China, 100021
Peking Union Medical College Hospital
Beijing, China, 100032
Peking University People's Hospital
Beijing, China, 100044
307 Hospital of PLA
Beijing, China, 100071
Chinese PLA General Hospital
Beijing, China, 100853
First Hospital of Jilin University
Changchun, China, 130021
West China Hospital
Chengdu, China, 610041
Fujian Provincial Tumor Hospital
Fuzhou, China, 350014
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
NanFang Hosptial
Guangzhou, China, 510515
The Third Affiliated Hospital of Harbin Medical University
Haerbin, China, 150081
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310009
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Qilu Hospital, Shangdong University
Jinan, China, 250012
the 81th Hospital of PLA
Nanjing, China, 210002
Shanghai Ruijin Hospital
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200033
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Wuhan Union Hospital
Wuhan, China, 430022
Hospital Ceske Budejovice
Ceske Budejovice, Czechia, 370 87
University Hospital Olomouc
Olomouc, Czechia, 775 20
General Faculty Hospital, Prague
Prague 2, Czechia, 128 08
MEDICON a.s., Praha 4
Praha 4, Czechia, 140 44
El Manial Specialized Hospital
Cairo, Egypt, 11553
Oncology Centre- Mansoura University
Mansoura, Egypt, 35516
HOP Amiens Sud, Onco, Amiens
Amiens Cedex 1, France, 80054
CTR P Papin, Onco, Angers
Angers Cedex 9, France, 49933
HOP Jean Minjoz
Besançon Cedex, France, 25030
CLI Bordeaux Nord Aquitaine
Bordeaux, France, 33300
CTR J Perrin, Onco, Clermont-Ferrand
Clermont-Ferrand Cedex, France, 63011
CTR Jean Bernard, Onco, Le Mans
Le Mans, France, 72000
CTR Catherine de Sienne
Nantes, France, 44202
HOP Saint-Louis
Paris, France, 75475
INS Jean Godinot, Onco, Reims
Reims, France, 51000
CTR Eugène Marquis
Rennes Cedex, France, 35042
CTR René Huguenin
St Cloud, France, 92210
CTR Paul Strauss
Strasbourg Cedex, France, 67065
Universitätsklinikum Aachen, AöR
Aachen, Germany, 52074
Medizinisches Zentrum Bonn
Bonn, Germany, 53111
Onkologische Gemeinschaftspraxis
Bottrop, Germany, 46236
Klinikum Deggendorf
Deggendorf, Germany, 94469
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Kliniken Essen - Mitte gGmbH
Essen, Germany, 45136
Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim
Hildesheim, Germany, 31134
Universitätsklinikum Köln (AöR)
Köln, Germany, 50931
St. Elisabeth-Krankenhaus
Köln, Germany, 50935
Universitätsklinikum Magdeburg AöR
Magdeburg, Germany, 39108
Klinikum der Universität München - Campus Innenstadt
München, Germany, 80337
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Onkologische Praxis Oldenburg
Oldenburg, Germany, 26121
Universitätsfrauenklinik am Klinikum Südstadt
Rostock, Germany, 18059
Facharzt für Innere Medizin
Wuppertal, Germany, 42105
Gujarat Cancer and Research Institute
Ahmedabad, India, 380016
Sujan Surgical Cancer Hospital
Amravati, India, 444606
KIDWAI memoraial Institute of oncology
Bangalore, India, 560029
Sri Venkateshwara Hospital
Bengaluru, India, 560068
Dr. Rai Memorial Cancer Centre
Chennai, India, 600018
Bibi General Hospital and Cancer Centre
Hyderabad, India, 500 024
Orchid Nursing Home
Kolkata, India, 700054
Natinal Cancer Institute
Maharagama, India
Shatabdi Superspeciality Hospital
Maharashtra, India, 422002
Central India Cancer Research Institute
Nagpur, India, 440 010
Curie Manavata Cancer centre
Nashik, India, 422004
Jehangir Hospital Oncology Department
Pune, India, 411001
K.E.M Hospital
Pune, India, 411011
King George Hospital
Visakhapatnam, India, 530002
Beaumont Hospital
Dubliin 9, Ireland
St Vincent's University Hospital
Dublin 4, Ireland
Mater Misericordiae University Hospital
Dublin 7, Ireland
St James's Hospital
Dublin 8, Ireland
Rambam Medical Center
Haifa, Israel, 31096
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, Israel, 91031
Meir Medical Center
Kfar Saba, Israel, 44281
The Chaim Sheba Medical Center Tel Hashomer
Tel Hashomer, Israel, 52621
Sourasky Medical Center
Tel-Aviv, Israel, 64239
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, Italy, 44124
Istituto Europeo di Oncologia
Milan, Italy, 20141
P.O. Monserrato
Monserrato (CA), Italy, 09042
Tokai University Hospital
Kanagawa, Isehara-shi, Japan, 259-1193
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, Japan, 537-8511
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of, 410-769
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Asan Medical Center
Seoul, Korea, Republic of, 138-736
P. Stradins Clinical Univ. Hospital, Oncology Clinic
Riga, Latvia, 1002
Riga East Univ. Hospital, Oncology Centre
Riga, Latvia, 1079
Hammoud Hospital University Medical Centre
Lebanon, Lebanon
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
Kaunas, Lithuania, 50009
National Cancer Institute, Vilnius
Vilnius, Lithuania, 08660
Hospital de Jesus
Colonia Centro, Mexico, 06090
Albert SchweitzerZiekenhuis
Dordrecht, Netherlands, 3318 AT
Máxima Medisch Centrum, locatie Eindhoven
Eindhoven, Netherlands, 3651 BM
Zuyderland Medisch Centrum
Geleen, Netherlands, 6162 BG
Zuyderland Medisch Centrum
Heerlen, Netherlands, 6419 PC
Medisch Ethische Commissie Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
Isala Zwolle
Zwolle, Netherlands, 8025 BP
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru, 84
Clinica San Judas Tadeo
Lima, Peru
Instituto Oncologico Miraflores S.A.
Miraflores, Peru
Clinica Peruano Americana de Trujillo
Trujillo, Peru
Bialystock's Oncology Center
Bialystok, Poland, 15-027
Wojewodzki Specialist Hospital No. 4, Bytom
Bytom, Poland, 41-902
University Clinical Center, Gdansk
Gdansk, Poland, 80-211
Provincial Specialist M. Kopernik Hospital
Lodz, Poland, 93-513
Ziemia Lubelska Oncological Center, Lublin
Lublin, Poland, 20-099
Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.
Olsztyn, Poland, 10-513
Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie
Poznan, Poland, 61-866
Military Medical Institute
Warsaw, Poland, 04 141
Instituto Português de Oncologia de Coimbra Francisco Gentil
Coimbra, Portugal, 3000-075
CHUC, EPE - CHC-Maternidade Bissaya Barreto
Coimbra, Portugal, 3041-801
IPO Lisboa Francisco Gentil, EPE
Lisboa, Portugal, 1099-023
Centro Hospitalar São João,EPE
Porto, Portugal, 420-451
IPO Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Russian Federation
Republic Clinical Oncology Dispensary, Dept. Chemotherapy
Kazan, Russian Federation, 420029
N.A. Semashko Central Clinical Hospital, Moscow
Moscow, Russian Federation, 129128
GUZ "Regional Clinical Oncology Dispensary"
Ryazan, Russian Federation, 390011
Regional Clinical Oncology Dispensary
Saint Petersburg, Russian Federation, 191104
National University Hospital
Singapore, Singapore, 119228
National Cancer Centre
Singapore, Singapore, 169610
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov
Bardejov, Slovakia, 085 01
National Institute of Oncology, Bratislava
Bratislava, Slovakia, 833 10
POKO Policlinic Dept. of Clinical Oncology
Poprad, Slovakia, 058 01
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
South Africa
Wits Donald Gordon Clinical Trial Site
Johannesburg, South Africa, 2193
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2196
GVI oncology Medi Clinic
Kraaifontein, South Africa, 7570
Langenhoven Drive Oncology Centre
Port Elizabeth, South Africa, 6045
Wilgers oncology
Pretoria, South Africa, 0041
Rondebosch Oncology Centre
Rondebosch, Cape Town, South Africa, 7700
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Dexeus
Barcelona, Spain, 08028
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Complejo Hospitalario Universitario Insular - Materno Infantil
Las Palmas de Gran Canaria, Spain, 35016
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Clínico de Santiago
Santiago de Compostela, Spain, 15706
Hospital Virgen de la Salud
Toledo, Spain, 45004
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Chang-Hua Christian Hospital
Changhua, Taiwan, 50006
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Taipe Veterans General Hospital
Taipei, Taiwan, 11217
Koo Foundation Sun Yet-Sen Cancer Center
Taipei, Taiwan, 112
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan County, Taiwan, 333
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD
Ankara, Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
Izmir, Turkey
United Kingdom
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Guy's Hospital
London, United Kingdom, SE1 9RT
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Queen Elizabeth Hospital
Woolwich, London, United Kingdom, SE18 4QH
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim Identifier: NCT01125566     History of Changes
Other Study ID Numbers: 1200.75
2009-015476-98 ( EudraCT Number )
First Posted: May 18, 2010    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: April 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action