Trial Title:
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
NCT ID:
NCT05814224
Condition:
Hormone Receptor Positive Breast Carcinoma
Breast Neoplasms
Neoplasms, Breast
Breast Diseases
Antineoplastic Agents
Aromatase Inhibitors
ESR1 Gene Mutation
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Breast Diseases
Conditions: Keywords:
Epigenetics
Liquid biopsy
ctDNA
ESR1 Gene Mutation
Biomarker
HR-positive HER2-negative
Advanced breast cancer
CDK4/6
Antineoplastic Agents Hormonal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid biopsy and CT scan
Description:
CT scan and liquid biopsy blood sample are performed at baseline, after 8 weeks from
baseline and, then, every 12 weeks.
Between two subsequent CT scan another liquid biopsy blood sample is performed.
CEA and CA 15.3 will be performed at baseline and then concomitantly to the radiological
evaluation
Arm group label:
Hormone-receptor positive MBC
Summary:
The purpose of the study is to determine the diagnostic role of ctDNA when used to
monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
Detailed description:
Patients with hormone receptor-positive MBC are eligible for endocrine therapy (ET) as
first line treatment which is based on strategies aimed to either block signaling
pathways depending on the estrogen receptor (ESR1) or using ESR1 antagonists. Only a few
accepted predictive factors are associated with treatment benefit for MBC (i.e., hormone
receptor status and HER2 status). Furthermore, a standardized assessment evaluation for
MBC is still lacking. Because of these unmet needs, ET is continued until disease
progression, or if toxicity requiring discontinuation occurs. Resistance is frequent in
the treatment of early BC and unavoidable in MBC. Recently, mutations in ESR1 have been
described in MBC that had been previously exposed to aromatase inhibitors (AIs) and are
rarely detectable in primary BC. Besides that, resistance phenomena have been also linked
to ESR1 cisregulatory elements (CRE, i.e. enhancers and promoters) hypermethylation, both
related to ESR1 silencing.
According to the literature, the aim of the study is to detect tumor response with liquid
biopsy technique compared to conventional clinical pratice algorithms.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically proven diagnosis of adenocarcinoma of the breast with evidence of
metastatic disease.
- ER positive tumor ≥ 1%
- HER2 negative breast cancer by FISH or IHC (IHC 0,1+, 2+ and/or FISH HER2: CEP17
ratio < 2.0)
- Females, 18 years of age or older
- Candidate to first-line endocrine therapy (LH-RH analogue for premenopausal women is
allowed)
- Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all the pertinent aspects of the
trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other trial procedures.
Exclusion Criteria:
- Diagnosis of any secondary malignancy within the last 3 years, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Prior endocrine therapy for metastatic disease
Gender:
Female
Gender based:
Yes
Gender description:
Females, 18 years of age or older
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asst Papa Giovanni Xxiii- Bergamo
Address:
City:
Bergame
Country:
Italy
Status:
Recruiting
Contact:
Last name:
CARLO ALBERTO TONDINI
Facility:
Name:
Centro di Riferimento Oncologico - Aviano
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Puglisi, MD
Phone:
0434 659310
Email:
fabio.puglisi@cro.it
Contact backup:
Last name:
Elisa De Crignis, PhD
Phone:
0434 659077
Email:
elisa.decrignis@cro.it
Facility:
Name:
Asst Ospedali Civili Di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
VITO AMOROSO
Facility:
Name:
Azienda Ospedaliero Universitaria Policlinico G. Rodolico- San Marco-Catania
Address:
City:
Catania
Country:
Italy
Status:
Recruiting
Contact:
Last name:
PAOLO VIGNERI
Facility:
Name:
Universita' Degli Studi Di Napoli Federico Ii
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
MARIO GIULIANO
Facility:
Name:
azienda sanitaria universitaria friuli centrale- Udine
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Contact:
Last name:
MARTA BONOTTO
Email:
giada.carpi@cro.it
Facility:
Name:
Ospedale San Bortolo- Azienda Ulss8 Berica
Address:
City:
Vicenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
LAURA MERLINI
Start date:
May 22, 2018
Completion date:
December 2024
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814224
