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

December 6, 2024 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD2014
Selective and potent inhibitor of mTOR kinase
Drug: Chemotherapy
in according to institutional guidelines
Experimental: Selumetinib
selective and potent inhibitor of MEK1/2 kinases
Drug: Chemotherapy
in according to institutional guidelines
Experimental: Olaparib
Inhibitor of the PARP enzyme involved in DNA repair
Drug: Chemotherapy
in according to institutional guidelines
Experimental: Bicalutamide
nonsteroidal antiandrogen
Drug: Chemotherapy
in according to institutional guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of progression-free survival
Time Frame: from baseline to the end of treatment (up to 12 months)
Comparison of progression-free survival in the experimental arm vs control arm
from baseline to the end of treatment (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Giuseppe Curigliano, MD, Istituto Eur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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