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NCT Number: NCT06727357

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer, Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

in according to institutional guidelines

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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