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

NCT ID: NCT06727357

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Breast Cancer, Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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AZD2014

Selective and potent inhibitor of mTOR kinase

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

in according to institutional guidelines

Selumetinib

selective and potent inhibitor of MEK1/2 kinases

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

in according to institutional guidelines

Olaparib

Inhibitor of the PARP enzyme involved in DNA repair

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

in according to institutional guidelines

Bicalutamide

nonsteroidal antiandrogen

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

in according to institutional guidelines

Interventions

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Chemotherapy

in according to institutional guidelines

Intervention Type DRUG

Eligibility Criteria

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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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Curigliano, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Eur

Locations

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Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IEO 674

Identifier Type: -

Identifier Source: org_study_id