A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00950300
First received: July 30, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of che motherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) con current with either SC Herceptin or IV Herceptin. After surgery patients will re ceive a further 10 cycles of Herceptin SC or IV as per randomization to complete

1 year of treatment. After the end of study treatment patients will be followed for safety and efficacy for at least 5 years, or until disease recurrence, whic hever is earlier.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Drug: docetaxel
Drug: 5-fluorouracil
Drug: epirubicin
Drug: cyclophosphamide
Phase 3

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 Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Trastuzumab) Administered in Women With HER2-positive Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Trastuzumab serum concentrations, comparing sc versus iv administration [ Time Frame: throughout cycles 1 to 8 ] [ Designated as safety issue: No ]
  • Pathological complete response [ Time Frame: after surgery between cycles 8 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trastuzumab serum concentrations, comparing sc versus iv administration after surgery [ Time Frame: throughout cycles 9 to 13 ] [ Designated as safety issue: No ]
  • Total pathologic complete response [ Time Frame: after surgery between cycles 8 and 9 ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: after 2, 4, 6 and 8 cycles of treatment ] [ Designated as safety issue: No ]
  • Progression and recurrence free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Immunogenicity (formation of anti-trastuzumab antibodies) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 596
Study Start Date: October 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC Drug: trastuzumab [Herceptin]
administered sc, day 1 of each 3-week cycle, 18 cycles
Drug: docetaxel
75 mg/sqm iv every 3 weeks, cycles 1 - 4
Drug: 5-fluorouracil
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: epirubicin
75 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: cyclophosphamide
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Active Comparator: IV Drug: trastuzumab [Herceptin]
administered iv, day 1 of each 3-week cycle, 18 cycles
Drug: docetaxel
75 mg/sqm iv every 3 weeks, cycles 1 - 4
Drug: 5-fluorouracil
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: epirubicin
75 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: cyclophosphamide
500 mg/sqm iv every 3 weeks, cycles 5 - 8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult women >/= 18 years of age
  • Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I-IIIC, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, HER2-positive
  • At least 1 measurable lesion in breast or lymph nodes according to RECIST v1.0 criteria, except for inflammatory carcinoma
  • Baseline LVEF >/= 55%

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
  • Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
  • Metastatic disease
  • Any prior therapy with anthracyclines
  • Prior anti-HER2 therapy or biologic or immunotherapy
  • Serious cardiac illness
  • Pregnant or lactating women
  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: NCT00950300

  Hide Study Locations
Locations
Argentina
Tucuman, Argentina, T4000IAK
Tucuman, Argentina, T400IAK
Brazil
Salvador, BA, Brazil, 41253-190
Curitiba, PR, Brazil, 80060-900
Natal, RN, Brazil, 59040150
Itajai, SC, Brazil, 88301-220
Jau, SP, Brazil, 17210-080
Sao Paulo, SP, Brazil, 01317-000
Sao Paulo, SP, Brazil, 01246-000
Sorocaba, SP, Brazil, 18030-245
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Canada
Quebec, Canada, G1S 4L8
Colombia
Bogota, Colombia, 000472
Bogota, Colombia
Pereira, Colombia
Czech Republic
Olomouc, Czech Republic, 775 20
Pardubice, Czech Republic, 532 03
Praha, Czech Republic, 140 59
Praha, Czech Republic, 180 81
Estonia
Tallin, Estonia, 11619
Tartu, Estonia, 50406
France
Besancon, France, 25030
Grenoble, France, 38000
La Tronche, France, 38700
Le Mans, France, 72015
Paris, France, 75475
Reims, France, 51056
St Cloud, France, 92210
Germany
Berlin, Germany, 10719
Berlin, Germany, 10117
Bonn, Germany, 53113
Dortmund, Germany, 44137
Hannover, Germany, 30177
Leipzig, Germany, 04277
Lemgo, Germany, 32657
Offenbach, Germany, 63069
Rodewisch, Germany, 08228
Tübingen, Germany, 72076
Guatemala
Guatemala, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong, 852
Hungary
Budapest, Hungary, 1083
Gyor, Hungary, 9023
Szeged, Hungary, 6701
Israel
Jerusalem, Israel, 91120-01
Petach Tikva, Israel, 49100
Italy
Napoli, Campania, Italy, 80131
Cremona, Lombardia, Italy, 26100
Pavia, Lombardia, Italy, 27100
Korea, Republic of
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 138-736
Mexico
Obregon, Mexico, 85000
Toluca, Mexico, 50180
Panama
Panama, Panama, 0834-02723
Peru
Arequipa, Peru, 04001
Lima, Peru, 41
Lima, Peru, 11
Piura, Peru, 20011
San Isidro, Peru, Lima 27
Poland
Elblag, Poland, 82-300
Lublin, Poland, 20-090
Olsztyn, Poland, 10-513
Warszawa, Poland, 02-781
Russian Federation
Ivanovo, Russian Federation, 153040
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Pyatigorsk, Russian Federation, 357502
Ryazan, Russian Federation, 390011
Saint-Petersburg, Russian Federation, 197758
Samara, Russian Federation, 443031
Saratov, Russian Federation, 410053
St Petersburg, Russian Federation, 197022
Stavropol, Russian Federation, 355045
Tula, Russian Federation, 300053
Vladimir, Russian Federation, 600009
Slovakia
Kosice, Slovakia, 04001
Poprad, Slovakia, 05801
South Africa
Bloemfontein, South Africa, 9301
Cape Town, South Africa, 7506
Johannesburg, South Africa, 2193
Pretoria, South Africa, 0081
Rondebosch, South Africa, 7700
Sandton, South Africa, 2196
Spain
Santiago de Compostela, La Coruña, Spain, 15706
Reus, Tarragona, Spain, 43204
Madrid, Spain, 28041
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Sweden
Lund, Sweden, 22185
Uppsala, Sweden, 75185
Taiwan
Changhua, Taiwan, 500
Taipei, Taiwan, 112
Taipei, Taiwan, 00112
Taipei, Taiwan, 105
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Songkhla, Thailand, 90110
Turkey
Antalya, Turkey, 07070
Istanbul, Turkey, 34390
Izmir, Turkey, 35340
S?hhiye, ANKARA, Turkey, 06100
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: NCT00950300     History of Changes
Other Study ID Numbers: BO22227, 2008-007326-19
Study First Received: July 30, 2009
Last Updated: July 14, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Trastuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 22, 2014