Breast Cancer Study
PACCT-1: Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal Therapy versus Adjuvant Hormonal Therapy Alone in Women with Previously resected Axillary Node-Negative Breast Cancer with Various Levels of Risk for Recurrence
Protocol ID
Protocol Description
The purpose of this study is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy, and to confirm that patients who have Oncotype DX Recurrence Score of less than or equal to 10 have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence). Another objective is to create a tissue and blood specimen bank that includes specimens from all women who participate in this study, and to collect follow-up information regarding the health status of all women who participate in the study.
Eligibility Criteria
Patients with breast cancer that is estrogen receptor and/or progesterone receptor positive that has not spread to the axillary lymph nodes.
Primary Investigator(s)
- Daniel Budman, MD