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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
60mg/m2 IV every 3 weeks for 4 cycles
600mg/m2 IV every 3 weeks for 4 cycles
75mg/m2 IV every 3 weeks for 4 cycles
National Cancer Center
Goyang-si, South Korea
RECRUITINGpathologic complete remission (pCR)
pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 \[MD Anderson definition\])
Time frame: within 6 weeks following the last dose of chemotherapy
Adverse events
Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: during 6 months of neoadjuvant chemotherapy
Response rate
Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria.
Time frame: during 6 months of neoadjuvant chemotherapy
Downstaging to breast conserving surgery (BCS)
Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy
Time frame: within 6 weeks following the last dose of chemotherapy
Disease free survival
Disease-free survival (DFS) following operation.
Time frame: Patients will be followed up to 6 years
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2.5 mg once daily preoperably
3.75 mg SC every 4 weeks for premenopausal patients