Breast Cancer, Metastatic Breast Cancer
Conditions
Brief summary
The present trial clinical proposes to randomize patients with cancer metastatic disease of the breast progressing on standard therapy to receive a treatment selected from 4 targeted drugs (a MEK kinase inhibitor, an mTOR kinase inhibitor, an of the enzyme involved in DNA repair PARP and an androgen receptor inhibitor) on the basis of possible presence of mutations in a panel of 61 genes analyzed on metastatic tissue from biopsy, or receive standard chemotherapy.
Interventions
DRUGChemotherapy
in according to institutional guidelines
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (women or men) with histologically confirmed metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Written informed consent obtained prior to enrollment * Age ≥ 18 years * Blood and tumor tissue sample available for research * Measurable disease * Other site accessible for biopsy, except bone lesions if this is the only accessible site, or biopsy obtained within the previous 6 months * Medical history, blood parameters and clinical conditions do not indicate major dysfunctions of organ To treatment: \- Maintenance of screening inclusion criteria
Exclusion criteria
* Presence of visceral crisis, defined according to ABC3/ESMO guidelines * Patients with local recurrence that can be treated with surgery and/or radiotherapy alone * Patients who have previously received palliative radiotherapy on the only site accessible to biopsy * Patients with metastatic disease limited to bone * Patients with metastatic disease limited to the brain, unless planned a surgical excision, in which case tissue can be collected for screening * Severe hematopoietic, renal and/or hepatic insufficiency * Known contraindication to biopsy * Neoplastic pathology of different histology in the previous 5 years, except carcinoma in situ of cervical basal or squamous cell carcinoma of the skin, if adequately treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of progression-free survival | from baseline to the end of treatment (up to 12 months) | Comparison of progression-free survival in the experimental arm vs control arm |
Countries
Italy
Outcome results
None listed