Clinical Trials

Title   Alliance A011106 (ALTERNATE)
Principal Investigator/ Physician   Lynn Dyess, MD
Protocol┬áNo.   A011106
Open Date   03/10/2014
Gender   Female
Cancer Site   Breast
Status   Open
Sponsor   Alliance for Clinical Trials in Oncology
Contact Email   MCI Clinical Trials

Protocol Title:  "ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant Treatment (ALTERNATE) in postmenopausal women: A Phase III Study (Alliance A011106)."

Inclusion criteria: ECOG performance status 0-2; Postmenopausal; Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy; Clinical T2-T4c, any N, M0 invasive breast cancer; estrogen receptor positive with an Allred score of 6, 7 or 8;  Invasive breast cancer is HER2 negative defined as 0 or 1+ by IHC

Exclusion criteria: Inflammatory breast cancer; Surgical axillary staging procedure prior to study entry; Clinical or radiographic evidence of metastatic disease; Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration; Tumor ER Allred score between 0-5 or HER2 positive by IHC (3+)

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