A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer


Tracking Information

Start Date  ICMJEOctober 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
  • trastuzumab serum concentrations, comparing sc versus iv administration [ Time Frame: throughout cycles 1 to 8 ] [ Designated as safety issue: No ]
  • pathologic complete response [ Time Frame: after surgery between cycles 8 and 9 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00950300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 30, 2009)
  • 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: after 2,4,6,8 and 18 cycles of treatment and after 6, 12 and 24 months of follow-up ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: event-driven ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • immunogenicity (formation of anti-trastuzumab antibodies) [ Time Frame: sampling at follow-up visits 3, 6, 12, 18 and 24 months after last dose of study drug ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer
Official Title  ICMJEA Randomized Open-label Study to Compare the Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Traztuzumab) Administered in Women With HER2-positive Early Breast Cancer.
Brief Summary

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 chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery patients will receive a further 10 cycles of Herceptin SC or IV as per randomization to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment for safety and efficacy. Target sample size is >500.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBreast Cancer
Intervention  ICMJE
  • Drug: Herceptin (trastuzumab)
    administered sc, day 1 of each 3-week cycle, 18 cycles
  • Drug: Herceptin (trastuzumab)
    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
Study Arms / Comparison Groups
  • SC: Experimental
    Interventions:
    • Drug: Herceptin (trastuzumab)
    • Drug: docetaxel
    • Drug: 5-fluorouracil
    • Drug: epirubicin
    • Drug: cyclophosphamide
  • IV: Active Comparator
    Interventions:
    • Drug: Herceptin (trastuzumab)
    • Drug: docetaxel
    • Drug: 5-fluorouracil
    • Drug: epirubicin
    • Drug: cyclophosphamide

Recruitment Information

Estimated Enrollment  ICMJE552
Estimated Completion DateOctober 2014
Primary Completion Date 
Eligibility Criteria  ICMJE

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
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO22227888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEArgentina,   Brazil,   Canada,   Colombia,   Costa Rica,   Czech Republic,   Ecuador,   Estonia,   France,   Germany,   Guatemala,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Panama,   Peru,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey

Administrative Information

NCT ID  ICMJENCT00950300
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBO22227, 2008-007326-19
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche