Addition of Trastuzumab to Chemotherapy Regimens Not
Evaluated in a Phase III Trial
➤ No phase III evidence exists for the addition of trastuzumab to some
chemotherapy regimens, such as docetaxel-cyclophosphamide. However,
those regimens might be in use and are reasonable options, particularly for
mitigating cardiotoxicity in certain patients.*
Duration of Trastuzumab Therapy and Cardiac Function
➤ Patients should be offered 1 year total of adjuvant trastuzumab with regular
assessments of cardiac function during that period.*
Adjuvant Capecitabine
➤ Patients with early stage HER2-negative breast cancer with pathologic
invasive residual disease at surgery following standard anthracycline and
taxane-based preoperative therapy may be offered up to 6–8 cycles of
adjuvant capecitabine. (Moderate Recommendation; EB-B-I)
Qualifying Statements: If clinicians decide to use capecitabine, then the Expert Panel
preferentially supports the use of adjuvant capecitabine in the hormone receptor-negative,
HER2-negative patient subgroup. The capecitabine dose used in the CREATE-X study
(1250 mg/m
2
twice daily) is associated with higher toxicity in patients ≥65 years old.
Adjuvant Pertuzumab
➤ Clinicians may add one year of adjuvant pertuzumab to trastuzumab-based
combination chemotherapy in patients with early-stage, HER2-positive breast
cancer. (Moderate Recommendation; EB-B-H)
Qualifying Statements: The Expert Panel preferentially supports pertuzumab in the node-
positive, HER2-positive population, in view of the clinically insignificant absolute benefit
observed among node-negative patients. After a median follow-up of 3.8 years, pertuzumab
was found to offer a modest disease-free survival benefit; the first planned interim analysis
did not show an overall survival benefit. There are no data to guide the duration of
pertuzumab in patients who received neoadjuvant pertuzumab and achieved a pathologic
complete response.
Treatment
