Status:
COMPLETED
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Agendia
Conditions:
Breast Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
Detailed Description
Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the b...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3.
- Co-enrollment in the FLEX Registry
- Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC)
- Patients should understand patients' condition and be able to give informed consent to participate
- Exclusion criteria
- History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer.
- Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs.
- Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer.
- Patients without invasive disease (stage 0)
- Patients with metastatic breast cancer(stageIV)
- Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).
Exclusion
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04129216
Start Date
February 20 2019
End Date
November 10 2022
Last Update
May 7 2024
Active Locations (1)
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1
Johns Hopkins Bayview Hospital
Baltimore, Maryland, United States, 21224