Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP

Phase 2

Active, not recruiting

• Conditions: Breast Cancer, Metastatic Breast Cancer
• Interventions: Drug: Chemotherapy

• Registration Number: NCT06727357
• Lead Sponsor: European Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Status Verified: 2024-09
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2014	Chemotherapy	Selective and potent inhibitor of mTOR kinase
Selumetinib	Chemotherapy	selective and potent inhibitor of MEK1/2 kinases
Olaparib	Chemotherapy	Inhibitor of the PARP enzyme involved in DNA repair
Bicalutamide	Chemotherapy	nonsteroidal antiandrogen

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy