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Protocol No.NSABP-B-47Principal InvestigatorTkaczuk, Kate
PhasePhase III
Age GroupAdult
TitleNSABP-B47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
DescriptionThis randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
Treatmentchemotherapy +/- Trastuzumab
Key EligibilityMust be female and greater than or equal to 18 years old. All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met as defined: By pathologic evaluation, primary tumor must be pT1-3 By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b,pN1c), pN2a, pN2b, pN3a, or pN3 If pN0, one of the following criteria must be met: pT2 and ER negative and PgR negative; or pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of greater than or equal to 25 HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low as defined by the protocol Must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy). (Patients who have had a nipple-sparing mastectomy are eligible.) The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below: Sentinel lymphadenectomy alone Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or Axillary lymphadenectomy with or without SN isolation procedure Patients with a primary tumor that is hormone receptor-positive or receptor-negative are eligible Must meet laboratory values as defined in protocol LVEF assessment must be performed within 90 days prior to randomization (exclusion criteria) Primary tumor with any of the following HER2 testing IHC staining intensity of 0 or 3+ FISH with a ratio of HER2 to CEP17 greater than or equal to 2.0 or HER2 copy number greater than or equal to 4 per nucleus CISH result indicating HER2-positive or HER2 gene copy number greater than or equal to 4 per nucleus Definitive clinical or radiologic evidence of metastatic disease Previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy Chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. Patients are eligible if these medications are discontinued prior to randomization Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens Hypertension defined according to the protocol Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor® EL Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
Applicable Disease SitesBreast - Female
Treatment TypeTherapeutic
ContactRes. Study Coordinator Jane Lewis, Registered Nurse Phone:410-328-7856
Pager:8-2337 #0449
Upper Chesapeake Hospital Natalie Lucas-Teter Phone:443-643-1029
Sr. Res. Nurse Coord. Nancy Tait, Registered Nurse Phone:410-328-3546
Pager:8-2337 #0943
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