Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
NCT03497702 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114
Last updated 2018-04-13
Summary
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Conditions
Interventions
- DRUG
-
Doxorubicin
60mg/m2 IV every 3 weeks for 4 cycles
- DRUG
-
600mg/m2 IV every 3 weeks for 4 cycles
- DRUG
-
75mg/m2 IV every 3 weeks for 4 cycles
- DRUG
-
2.5 mg once daily preoperably
- DRUG
-
leuprorelin
3.75 mg SC every 4 weeks for premenopausal patients
Sponsors & Collaborators
-
National Cancer Center, Korea
lead OTHER_GOV
Principal Investigators
-
Keun Seok Lee, MD, PhD · National Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-08
- Primary Completion
- 2023-11-30
- Completion
- 2024-01-31
Countries
- South Korea
Study Locations
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