Clinical trial NCT04129216: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Official title: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
genomic assay
hormone therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Agendia
First posted: 2019-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy
Primary purpose: BASIC_SCIENCE

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 breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study 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.

The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
timeFrame: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
Secondary outcomes:
measure: Number of Participants With Low or High Score in MammaPrint
timeFrame: Baseline and at Time of surgery (up to 6 weeks)
measure: Median Percent of Tissue ER Positive
timeFrame: Baseline and at Time of surgery (up to 6 weeks)
measure: Median Percent of Tissue PR Positive
timeFrame: Baseline and at Time of surgery (up to 6 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Bayview
name: Mehran Habibi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01.