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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overPharmaceutical / IndustryBO22227
2008-007326-19, NCT00950300

Trial Description


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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

    Clinical Trials, Study Director

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00950300
    ClinicalTrials.gov processed this data on May 26, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.