Status:
RECRUITING
Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 l...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 18 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06129786
Start Date
May 18 2023
End Date
May 18 2026
Last Update
November 13 2023
Active Locations (2)
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1
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, Italy, 33081
2
Azienda Sanitaria Universitaria del Friuli Centrale(ASUFC)
Udine, Italy, 33100