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A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545688
First Posted: October 17, 2007
Last Update Posted: August 15, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Breast Cancer Drug: Herceptin Drug: Docetaxel Drug: Pertuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Achieving Pathological Complete Response (pCR) [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4) ]
    pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders

  • Percentage of Participants Achieving pCR by Breast Cancer Type [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4) ]
    pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.

  • Percentage of Participants Achieving pCR by Hormone Receptor Status [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4) ]
    pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.

  • Percentage of Participants Achieving pCR by Lymph Node Status [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4) ]
    pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.

  • Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS) [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4) ]
    pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography [ Time Frame: Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.

  • Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.

  • Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.

  • Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.

  • Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Overall response is derived based on the sum total of breast tumors and all nodes examined.

  • Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Primary breast tumor clinical response is based on primary breast tumor assessment. Overall response is derived based on the sum total of breast tumors and all nodes examined.

  • Time to Clinical Response During Neo-Adjuvant Treatment Period [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment.

  • Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period [ Time Frame: Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ]
    Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: PD: if lesion is at least a 20 % increased from measurements at baseline. Percentage of participants along with 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method were reported. Missing investigator assessments were considered as no progressive disease.

  • Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned [ Time Frame: Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months ]
    Breast Conserving Surgery (BCS) was defined as quadrantectomy, lumpectomy, no surgery, sentinel node biopsy, axillary surgical resection or other method of avoiding mastectomy.

  • Percentage of Participants Who Were Progression Free and Disease Free [ Time Frame: Randomization up to a maximum of 329 weeks ]
    Disease-free survival (DFS) was defined as the time from first date of no disease to first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from the study without documented progression and for whom evaluations were made, were censored at date of last assessment when participant was known to be disease-free. Progression-free survival (PFS) was defined as time from date of randomization to first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from study without documented progression and for whom evaluations were made, were censored at date of last assessment when the participant was known to be free from progressive disease. Participants without post baseline assessments but known to be alive were censored at the time of randomization.

  • Progression Free and Disease Free Survival [ Time Frame: Randomization up to a maximum of 329 weeks ]
    DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.


Enrollment: 417
Actual Study Start Date: June 26, 2006
Study Completion Date: September 22, 2014
Primary Completion Date: September 22, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Other Name: Trastuzumab
Drug: Docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Experimental: 2 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Other Name: Trastuzumab
Drug: Docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Drug: Pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Experimental: 3 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Other Name: Trastuzumab
Drug: Pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Experimental: 4 Drug: Docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Drug: Pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • female patients, >=18 years of age;
  • locally advanced, inflammatory or early stage invasive breast cancer;
  • HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

  • metastatic disease (Stage IV) or bilateral breast cancer;
  • previous anticancer therapy or radiotherapy for any malignancy;
  • other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
  • insulin-dependent diabetes;
  • clinically relevant cardiovascular disease.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00545688


  Hide Study Locations
Locations
Australia, Victoria
Geelong Hospital; Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Mount Medical Center
Perth, Western Australia, Australia, 6000
Austria
Kaiser Franz Josef Spital; Iii. Medizinische Abt. Mit Onkologie
Vienna, Austria, 1100
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Wien, Austria, 1090
Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui, RS, Brazil, 98700-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-080
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo Andre, SP, Brazil, 09060-650
Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica
Sao Paulo, SP, Brazil, 01221-020
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia
Sao Paulo, SP, Brazil, 03102-002
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, SP, Brazil, 18030-245
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University; Montreal General Hosptial; Oncology
Montreal, Quebec, Canada, H3G 1A4
Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Quebec, Canada, G1S 4L8
Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 91120-01
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv, Israel, 6423906
Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
Bologna, Emilia-Romagna, Italy, 40138
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, Italy, 43100
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
ASST OVEST MILANESE; Oncologia Medica
Legnano, Lombardia, Italy, 20025
Ospedale San Raffaele, Servizio di Oncologia e Chemioterapia
Milano, Lombardia, Italy, 20132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia, Italy, 20133
Ospedale Calvi di Noale; U.O. Complessa di Oncologia ed Ematologia Oncologica
Mirano, Veneto, Italy, 30035
Polo Ospedaliero Santorso
Santorso, Veneto, Italy, 36014
Ospedale Di Vicenza; Nefrologia, Oncologia Medica
Vicenza, Veneto, Italy, 36100
Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, Korea, Republic of, 135-710
Mexico
Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, Mexico, 06700
Issstep Puebla, ; Oncology
Puebla, Mexico, 72530
Peru
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
Arequipa, Peru, 5154
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Lima, Peru, 11
Poland
Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej
Lublin, Poland, 20-081
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, Poland, 20-090
Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.
Olsztyn, Poland, 10-513
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, Poland, 60-569
NZOZ Centrum Medyczne HCP Sp. z o.o.
Poznan, Poland, 61-485
Central Hospital of Military School of Medicine; Oncology
Warszawa, Poland, 00-909
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warszawa, Poland, 02-781
Russian Federation
FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
St Petersburg, Leningrad, Russian Federation, 197758
SI of Healthcare Kazan Oncology Dispensary
Kazan, Russian Federation, 420111
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
NSI of Healthcare Central Clinical Hospital #2 n.a. N.A.Semashko of the Russian Railways
Moscow, Russian Federation, 129128
State Institution Of Healthcare Republican Oncology Dispensary
Petrozavodsk, Russian Federation, 185007
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Russian Federation, 357502
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
Ryazan, Russian Federation, 390011
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
SI of HealthCare Oncologic Dispensary #2 of department of healthcare of Krasnodar region
Soshi, Russian Federation, 354057
SBI of Healthcare Leningrad Regional Oncology Dispensary
St Petersburg, Russian Federation, 191104
Ulyanovsk Regional Oncology Dispensary; Chemotherapy
Ulyanovsk, Russian Federation, ND
Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sweden
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, Sweden, 17176
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 75185
Switzerland
Kantonsspital Baden; Frauenklinik
Baden, Switzerland, 5405
Brustzentrum
Zürich, Switzerland, 8008
Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, Taiwan, 00112
National Taiwan Uni Hospital; Dept of Oncology
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, Taiwan, 112
Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok, Thailand, 10330
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Prince of Songkla Uni ; Unit of Medical Oncology
Songkhla, Thailand, 90110
Turkey
Dokuz Eylul Uni Medical Faculty; Oncology Dept
Izmir, Turkey, 35340
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Walsgrave Hospital; Dept of Oncology
Coventry, United Kingdom, CV2 2DX
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545688     History of Changes
Other Study ID Numbers: WO20697
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: December 16, 2015
Results First Posted: January 26, 2016
Last Update Posted: August 15, 2017
Last Verified: July 2017

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