Clinical Trials Navicent Health

Protocol #

NSABP B-47
Invasive Breast Cancer

Title

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

Stage

T 1-3, N 0-3, M0 diagnosis of invasive breast cancer by FNA or core needle biopsy
If lymph node negative, must be T2 and ER/PR negative or T2 and ER positive and either grade 3 or Oncotype RS 25 or greater.  Her2-neu must be 1+ or 2+ by IHC testing.

Overview of Treatment

Patient will be randomized randomized (assigned to a group by chance) to receive Trastuzumab (Herceptin) x 1 year, along with chemotherapy chosen by medical oncologist, which consists of either Adriamycin + Cytoxan (x4 doses) followed by weekly Taxol (x12 doses) or Taxotere + Cytoxan (x6 doses).

Study –provided

 Trastuzumab

Contact

For more information or questions, call Andrew Weatherall (478) 633-2152

 

Protocol # NSABP B-43
(DCIS)
Title A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Stage Stage 0 DCIS or mixed DCIS & LCIS removed by lumpectomy and be HER2+ by central testing.
Overview of treatment After tissue from lumpectomy is sent to Duke University for central testing and found to be HER2+, patient will be randomized (assigned to a group by chance) to receive radiation therapy alone or radiation therapy plus 2 doses of Trastuzumab (Herceptin) IV, 3 weeks apart, during radiation therapy.
Study-provided HER2 tissue testing at no charge to patient or insurance.Trastuzumab
Contact For more information or questions, call Andrew Weatherall (478) 633-2152

 


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