Actively Recruiting
Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2023-11-13
74
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease.
- ER positive tumor 63 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.
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, Italy, 33081
Actively Recruiting
2
Azienda Sanitaria Universitaria del Friuli Centrale(ASUFC)
Udine, Italy, 33100
Actively Recruiting
Research Team
F
Fabio Puglisi, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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