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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   S1007 - " A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients iwth 1-3 Postiive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score of 25 or less"
Description   Primary Objective:
To determine the effect of chemotherapy in paitients with node positive breast cancer who do no have high Recurrence Scores (RS) by Oncotyp eDX. In patients with 1-3 positive nodes, and hormone receptor (HR) -positive, HER2-negative breast cancer with RS<25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for reommending chemotherapy or not.
Treatment   Oncology
Inclusion/Notes   ELIGIBILITY:
- Patient must have a histologically confirmed diagnosis of node positive (1-3nodes) invasive breast carcinoma iwth
positive ER and/or PR status. ER and PR positivity must be assessed according to ASCO/CAP guidelines. If HER2 IHC
is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of <2.2)
- Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed.
- Patients will have undergone axillary stagine by sentinel node biopsy or axillary lymph nodes dissection (ALND). - - Patients must have at least one, but no more than three known positive lymph nodes (pN1mi, pN1a, pN1b or pN1c),.
- Patients with positive sentinel node are not required to undergo full axillary lymph node dissection., this is
at discretion of the treating physician.
- patients must not have inflmammatory breast cancer and must not have metastatic disease. Patients with a prior
- diagnosis of DCIS are eligible if they received mastectomy alone. Radiation in the opposite breast is acceptable.

- Patients must have had either breast -conserving surgery iwht planned rT ir titak nastectint, Oatuebts nyst gave ckear a=nargubs,
' -Registration of patient swho have not yet undergone Oncotype DX screenign must occur no later than 56 days after definitive surgery.
- P{atients must be females > 18 years of age.
- Patients must have a PS of 0-2 by Zubrod criteria
Patients mustw not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
- Patients must not have received preventive tamoxifgen or raloxifene for prevention of breast cancer, or have received prior therapeutic ipsilateral obrast radiation, unless it partial breast irradiation for the index tumor.
- Patients must nob e pregnannt or nursing due to possibility of harm to fetur or nursing infant from this treatment regimen.
- No other prior malignancy is allowed excpet fo the foolwing, adequately treated basal cell or squamous cell skin cancer, in situcervical cancer, adquatly treated Stage 0,1 or II cancer from which the patient si currently in complete remisison, or any ohter cancer from which te paatient has been disease-free for 5 years.
- All patient must be informed of the invetigational nature of theis study and must sign and give written informed consent.
Status   accruing
Current Trial Type   treatment

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