Addressing treatment resistance in advanced breast cancer
Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)
This study is testing if certain biological markers can help doctors understand how well advanced breast cancer patients respond to new treatments after their cancer comes back or is newly diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aviano, Pordenone and 1 other locations) |
| Trial ID | NCT06129786 on ClinicalTrials.gov |
What this trial studies
This observational project focuses on patients with advanced breast cancer who either have a new diagnosis or have experienced disease recurrence after more than 12 months of adjuvant endocrine therapy. It aims to identify biomarkers that predict responses or resistance to endocrine therapy and CDK4/6 inhibitors, which are critical for tailoring effective treatment strategies. The study will analyze clinical characteristics and molecular factors to improve therapeutic outcomes for patients facing primary or secondary resistance to treatment.
Who should consider this trial
Good fit: Ideal candidates include females aged 18 and older with ER-positive, HER2-negative metastatic breast cancer who are candidates for first-line endocrine therapy.
Not a fit: Patients with a history of secondary malignancies within the last three years or those who have previously received endocrine or chemotherapy for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced breast cancer.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for treatment resistance in breast cancer, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aviano, Pordenone and 1 other locations
- Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano, Pordenone, Italy (Recruiting)
- Azienda Sanitaria Universitaria del Friuli Centrale(ASUFC) — Udine, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Puglisi, MD,PhD — Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
- Study coordinator: Fabio Puglisi, MD, PhD
- Email: fabio.puglisi@cro.it
- Phone: +39 0434 659253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.