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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545688
First received: October 16, 2007
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatmen t 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-w eekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and doceta xel 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 an ticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Breast Cancer
Drug: pertuzumab
Drug: Herceptin
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Pathological complete response rate [ Time Frame: Post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free interval, PFS, breast-conserving surgery rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, LVEF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: June 2006
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Experimental: 2 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Experimental: 3 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Experimental: 4 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545688

  Hide Study Locations
Locations
Australia, Victoria
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Austria
Vienna, Austria, 1100
Wien, Austria, 1090
Brazil
Ijui, RS, Brazil, 98700-000
Porto Alegre, RS, Brazil, 91350-200
Itajai, SC, Brazil, 88301-220
Jau, SP, Brazil, 17210-080
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 03102-002
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 01317-000
Sorocaba, SP, Brazil, 18030-245
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Kingston, Ontario, Canada, K7L 5P9
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3G 1A4
Canada
Quebec, Canada, G1S 4L8
Israel
Jerusalem, Israel, 91120-01
Kfar-Saba, Israel, 4428164
Tel Aviv, Israel, 6423906
Italy
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43100
Udine, Friuli-Venezia Giulia, Italy, 33100
Legnano, Lombardia, Italy, 20025
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20133
Mirano, Veneto, Italy, 30035
Santorso, Veneto, Italy, 36014
Vicenza, Veneto, Italy, 36100
Korea, Republic of
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Mexico
Aguascalientes, Mexico, 20230
Mexico City, Mexico, 06700
Puebla, Mexico, 72530
Peru
Arequipa, Peru, 5154
Lima, Peru, 11
Poland
Lublin, Poland, 20-090
Lublin, Poland, 20-081
Olsztyn, Poland, 10-513
Poznan, Poland, 60-569
Poznan, Poland, 61-485
Warszawa, Poland, 00-909
Warszawa, Poland, 02-781
Russian Federation
Kazan, Russian Federation, 420111
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 129128
Petrozavodsk, Russian Federation, 185007
Pyatigorsk, Russian Federation, 357502
Ryazan, Russian Federation, 390011
Saint-Petersburg, Russian Federation, 197758
Samara, Russian Federation, 443031
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 191104
Ulyanovsk, Russian Federation, ND
Spain
Sabadell, Barcelona, Barcelona, Spain, 08208
Barakaldo, Vizcaya, Spain, 48903
Cordoba, Spain, 14004
Madrid, Spain, 28034
Madrid, Spain, 28046
Madrid, Spain, 28041
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Sweden
Stockholm, Sweden, 17176
Uppsala, Sweden, 75185
Switzerland
Baden, Switzerland, 5405
Zürich, Switzerland, 8008
Taiwan
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10400
Songkhla, Thailand, 90110
Turkey
Izmir, Turkey, 35340
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
Coventry, United Kingdom, CV2 2DX
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received: October 16, 2007
Last Updated: July 28, 2014
Health Authority: Italy: AIFA (Agenzia Italiana Farmaco)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014