Breast Cancer Clinical Trial
Official title:
Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of
neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by
adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the
postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with
chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or
additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the
tumors are still in vivo by treating patients with an aromatast inhibitor combined with
chemotherapy before surgery and assessing pCR rates.
PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and
axilla.
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