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Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (413) 443-6000
Fax   (413) 443-2203
Title   B-47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High Risk N ode-Negative HER2-Low Invasive Breast Cancer
Description   The purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
- IHC score (1+,2+)
- Number of positive nodes (0-3, 4-9, 10+)
- Hormone receptor status (ER-[ositive and/or PgR-positive, ER- and PgR-negative)
- Intended chemotherapy regiemn (TC [Docetaxel + cyclophosphamide], AC followed by WP [doxorubicin + cyclophosphamide follwed by weekly pactlitaxel])

Arm 1 Arm 2
(groups 1A and 1B) (Groups 2A and 2B)
Chemotherapy Chemotherapy
(TC or AC followed by WP) +
Trastuzumab x 1 year
(TC + trastuzumab or
AC followed by WP + trastuzumab)

Treatment   Oncology
Inclusion/Notes   Eligiblity:
- signed consent
- female
- must be over 18 years old
- ECOG performance status of 0 or 1
- tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
- appropriate staging criteria must be met (7th Ediction of AJCC Cancer Staging Manual)
- HER2 status of primary tumor must be evaluated prior to randomiation
- patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)
- patient must have completed a pathologic nodal status
- ER analysis performed on primary tumor prior to randomization
- appropriate blood tests meeting eligibility criteria

- T4 tumors including inflammatory breast cancer
- definitive clinical or radiologic evidence of metastatic disease
- previous history of ipsilateral invasive breast cancer or ipsilateral DCIS
- history of non-breast malignancies within 5 years prior to randomization
- previous chemotherapy
- active hepatitis B or hepatitis C with abnormal liver function tests
- poorly controlled diabets mellitus
Status   accruing
Current Trial Type   treatment

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