"Trastuzumab for HER2-Positive Early Breast Cancer". The New England Journal of Medicine. 2005. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with HER2-positive early-stage breast cancer who have completed locoregional therapy and chemotherapy, does trastuzumab therapy improve disease-free survival?
A year of trastuzumab therapy after adjuvant chemotherapy significantly improves disease-free survival amongst women with HER2-positive early-stage breast cancer.
HER2-positive breast cancer is aggressive and trastuzumab, a monoclonal antibody targeting HER2, improves outcomes in metastatic breast cancer. The HERA (HERceptin Adjuvant) trial explored the efficacy and safety of trastuzumab after completion of locoregional and chemotherapeutic treatment in early-stage breast cancer.
Trastuzumab is now a standard part of treatment for HER2-positive early breast cancer following primary treatment based on these trial results.
- International, multicenter, randomized, open-label trial - N=5,081 patients with HER2-positive early-stage invasive breast cancer - Trastuzumab for 1 year (n=1,694) vs. Observation (n=1,693) - Enrollment: December 2001 to March 2005 - Mean follow-up: 1 year
- Women with early-stage invasive breast cancer with overexpressed or amplified HER2 after locoregional therapy and at least four cycles of chemotherapy - Median age: 49 years
Inclusion Criteria - Histologically confirmed invasive breast cancer with overexpression or amplification of HER2 - Completed locoregional therapy - At least four cycles of chemotherapy - Adequate baseline organ function
Exclusion Criteria - Distant metastases - Previous invasive breast carcinoma - Previous neoplasm not involving the breast - Clinical stage T4 tumor or involvement of supraclavicular nodes - LVEF < 55%
- Trastuzumab: 8 mg/kg IV once, followed by 6 mg/kg IV every three weeks for one year - Observation: No trastuzumab administration
Primary Outcome - Disease-free survival, defined as time from randomization to the first occurrence of breast cancer recurrence, contralateral or ipsilateral cancer, second nonbreast cancer, or death from any cause
- Cardiac safety, overall survival, site of the first disease-free survival event, time to distant recurrence
- Short follow-up period - Potential long-term risks of cardiotoxicity are unknown - Unclear if trastuzumab effectively reduces incidence of disease recurrence in the central nervous system
- Supported by F. Hoffmann–La Roche (Roche), Basel, Switzerland
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