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Trial Title:
Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)
NCT ID:
NCT06129786
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Patients presenting with a de novo diagnosis of luminal-like advanced breast cancer (ABC)
or with disease recurrence after >12 months from the end of adjuvant ET, are generally
candidate to a first line therapy with an aromatase inhibitor in association with a
CDK4/6i. Disease recurrence in <12 months from the end of adjuvant ET defines the disease
as "endocrine resistant" and identifies patients that should receive a first line therapy
with the selective estrogen receptor degrader (SERD) Fulvestrant in association with the
CDK4/6i Ribociclib, according to the results of the MONALEESA-3 trial.
A significant percentage of ABC patients develops a primary resistance with disease
progression within the first 6 months from the beginning of the treatment. Furthermore,
another relevant percentage of patients initially responding to the therapy, will later
develop a secondary resistance, thus progressing after a median of 2 years from the
beginning of the treatment. Thereby, it is crucial to identify biomarkers that could be
predictive of a response or a resistance to ET and/or CDK4/6i, to provide the best
therapeutic strategy, tailored upon both clinico-pathological and molecular
characteristics.
Numerous pathways associated with resistance to CDK4/6i have been investigated by means
of liquid biopsy analysis. The aim of this study is to identify potential biomarkers
predictive of a clinical benefit in patients receiving a first line therapy with
AI/fulvestrant (+/- LH-RH analogue) in association with a CDK4/6i for luminal-like
advanced breast cancer.
Detailed description:
Patients presenting with a de novo diagnosis of luminal-like advanced breast cancer (ABC)
or with disease recurrence after >12 months from the end of adjuvant ET, are generally
candidate to a first line therapy with an aromatase inhibitor (+/- LH-RH analogue
depending from the menopausal status) in association with a CDK4/6i. Disease recurrence
in <12 months from the end of adjuvant ET defines the disease as "endocrine resistant"
and identifies patients that should receive a first line therapy with the selective
estrogen receptor degrader (SERD) Fulvestrant in association with the CDK4/6i Ribociclib,
according to the results of the MONALEESA-3 trial.
The choice of the endocrine backbone and of the CDK4/6i is mostly influenced by the
patient's clinical characteristics and by disease factors.
However, a significant percentage of ABC patients develops a primary resistance with
disease progression within the first 6 months from the beginning of the treatment.
Furthermore, another relevant percentage of patients initially responding to the therapy,
will later develop a secondary resistance, thus progressing after a median of 2 years
from the beginning of the treatment. Thereby, it is crucial to identify biomarkers that
could be predictive of a response or a resistance to ET and/or CDK4/6i, to provide the
best therapeutic strategy, tailored upon both clinico-pathological and molecular
characteristics.
Numerous pathways associated with resistance to CDK4/6i have been investigated by means
of liquid biopsy analysis. The aim of this study is to identify potential biomarkers
predictive of a clinical benefit in patients receiving a first line therapy with
AI/fulvestrant (+/- LH-RH analogue) in association with a CDK4/6i for luminal-like
advanced breast cancer.
Criteria for eligibility:
Study pop:
Women with hormone receptor-positive ABC, considered eligible for endocrine therapy as
first line endocrine treatment
Sampling method:
Non-Probability Sample
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 pre-menopausal 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
- Prior chemotherapy for metastatic disease
- Patients unwilling to or unable to comply with the protocol.
- Known CNS metastases
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Puglisi, MD, PhD
Email:
fabio.puglisi@cro.it
Investigator:
Last name:
Fabio Puglisi, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Barbara Belletti, PhD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria del Friuli Centrale(ASUFC)
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro Marco Minisini, MD
Phone:
0432 552751
Email:
alessandro.minisini@asufc.sanita.fvg.it
Investigator:
Last name:
Alessandro Marco Minisini, MD
Email:
Principal Investigator
Start date:
May 18, 2023
Completion date:
May 18, 2026
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/NCT06129786
