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

NCT06727357 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IEO 674
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer, Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of progression-free survival

  Comparison of progression-free survival in the experimental arm vs control arm

  from baseline to the end of treatment (up to 12 months)

Study Arms (4)

AZD2014

EXPERIMENTAL

Selective and potent inhibitor of mTOR kinase

Drug: Chemotherapy

Selumetinib

EXPERIMENTAL

selective and potent inhibitor of MEK1/2 kinases

Drug: Chemotherapy

Olaparib

EXPERIMENTAL

Inhibitor of the PARP enzyme involved in DNA repair

Drug: Chemotherapy

Bicalutamide

EXPERIMENTAL

nonsteroidal antiandrogen

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

in according to institutional guidelines

AZD2014; Bicalutamide; Olaparib; Selumetinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Giuseppe Curigliano, MD

  Istituto Eur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 10, 2024
• Study Start: September 26, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-09

Locations

IT (1)