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Clinical Trials (PDQ®)

A Study on Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in Patients With HER2-Positive Early Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IINatural history/Epidemiology, TreatmentClosed18 and overPharmaceutical / IndustryMO22982
NCT01401166

Trial Description

Summary

This randomized, open-label, crossover study will evaluate patients' preference and healthcare professional satisfaction with Herceptin (trastuzumab) subcutaneo us (sc) versus intravenous (iv) administration in patients with HER2-positive ea rly breast cancer. Patients will be randomized to receive either Herceptin 600 m g sc or Herceptin 6 mg/kg iv every 3 weeks for Cycles 1-4, then cross over to th e other treatment administration for Cycles 5-8. For Cycles 9-22, all patients w ill be administered iv Herceptin at 6 mg/kg every 3 weeks. Anticipated time on s tudy treatment is 66 weeks.

Eligibility Criteria

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • HER2-positive breast cancer
  • No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant)
  • All adjuvant chemotherapy must be completed, adjuvant radiotherapy may be ongoing
  • Patients who have already received IV Herceptin must have at least 10 out of the total planned 18 3-week cycles remaining
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years
  • Inadequate bone marrow function
  • Impaired liver function
  • Inadequate renal function
  • Serious cardio-vascular disease
  • HIV or hepatitis B (HBV) or C (HCV) infection
  • Prior maximum cumulative dose of doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2 or equivalent

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01401166
ClinicalTrials.gov processed this data on October 20, 2014

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.

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