Breast Cancer, Metastatic Breast CancerPhase 2NCT06727357
Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP
A Phase 2 study testing Chemotherapy in people with Breast Cancer, Metastatic Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2019to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
in according to institutional guidelines
| Study group | Role | What they receive |
|---|---|---|
| AZD2014 | Experimental | Selective and potent inhibitor of mTOR kinase Receives: Drug: Chemotherapy |
| Selumetinib | Experimental | selective and potent inhibitor of MEK1/2 kinases Receives: Drug: Chemotherapy |
| Olaparib | Experimental | Inhibitor of the PARP enzyme involved in DNA repair Receives: Drug: Chemotherapy |
| Bicalutamide | Experimental | nonsteroidal antiandrogen Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of progression-free survival
Comparison of progression-free survival in the experimental arm vs control arm
Measured: from baseline to the end of treatment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 Sep 2019
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Curigliano, MD, Principal investigator, Istituto Eur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727357
- Sponsor's protocol ID
- IEO 674
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of a Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP
- ClinicalTrials.gov ID
- NCT06727357
- Acronym / sponsor ID
- IEO 674
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD2014 | Experimental | Drug: ChemotherapySelective and potent inhibitor of mTOR kinase |
| Selumetinib | Experimental | Drug: Chemotherapyselective and potent inhibitor of MEK1/2 kinases |
| Olaparib | Experimental | Drug: ChemotherapyInhibitor of the PARP enzyme involved in DNA repair |
| Bicalutamide | Experimental | Drug: Chemotherapynonsteroidal antiandrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapyin according to institutional guidelines | Drug | AZD2014, Bicalutamide, Olaparib, Selumetinib |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Curigliano, MD principal investigator
Istituto Eur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy in people with Breast Cancer, Metastatic Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of progression-free survival (time frame: from baseline to the end of treatment (up to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.