BRCA-Associated Breast CarcinomaGen-evaNCT05763472
Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation
An observational study of BRCA-Associated Breast Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA-Associated Breast Carcinoma
- What is being tested?
- Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 1 Jun 2023
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer
Who may be able to join
- Written informed consent.
- Age older than 18 years.
- Germline BRCA1/2 mutation.
- Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.
- Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.
- Availability of FFPE breast and ovarian tumor samples.
Who cannot join
- Other malignancies in the last 2 years.
- Prior chemotherapy or radiation therapy for other malignancies.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RM, 00168
IDA PARIS, MD, +39 0630156493, ida.paris@policlinicogemelli.it
About this study
Official title: Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer
This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.
- Conditions
- BRCA-Associated Breast Carcinoma
- Being tested
- Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).
- Keywords
- BRCA1/2, Breast cancer, Ovarian cancer, Platinum salts, PARP inhibitors
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).Genetic
Next-generation sequencing (NGS) analysis with TruSight Oncology 500 (TSO 500) is performed on tumor samples from breast and ovarian cancer of the enrolled patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with germline BRCA1/2 patitents | Women with germline BRCA-1/2 mutations, previously treated or undergoing treatment with platinum-based chemotherapy and/or PARP inhibitors for ovarian cancer, who have developed breast cancer, subjected to genomic profiling of breast and ovarian tumor samples. Receives: Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast somatic mutations
To describe the presence of somatic mutations on breast tumor tissue, in patients with breast cancer arising during or after treatment with platinum-based chemotherapy or PARP-inhibitors for ovarian cancer.
Measured: 15 months
Secondary outcomes (1)
Ovarian somatic mutations
To describe the presence of somatic mutations on ovarian tumor tissue, in patients with breast cancer arising during or after treatment with platinum-based chemotherapy or PARP-inhibitors for ovarian cancer.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA-Associated Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763472
- Sponsor's protocol ID
- 4817
- Acronym
- Gen-eva
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05763472
- Acronym / sponsor ID
- Gen-eva / 4817
- Conditions
- BRCA-Associated Breast Carcinoma
- Keywords
- BRCA1/2, Breast cancer, Ovarian cancer, Platinum salts, PARP inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Mar 2023 (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.
This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with germline BRCA1/2 patitents | – | Genetic: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).Women with germline BRCA-1/2 mutations, previously treated or undergoing treatment with platinum-based chemotherapy and/or PARP inhibitors for ovarian cancer, who have developed breast cancer, subjected to genomic profiling of breast and ovarian tumor samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer
Key inclusion criteria (6 listed)
- Written informed consent.
- Age older than 18 years.
- Germline BRCA1/2 mutation.
- Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.
- Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.
Key exclusion criteria (2 listed)
- Other malignancies in the last 2 years.
- Prior chemotherapy or radiation therapy for other malignancies.
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 |
|---|---|---|
| Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).Next-generation sequencing (NGS) analysis with TruSight Oncology 500 (TSO 500) is performed on tumor samples from breast and ovarian cancer of the enrolled patients. | Genetic | Patients with germline BRCA1/2 patitents |
Primary outcome
Breast somatic mutations
Time frame: 15 months
To describe the presence of somatic mutations on breast tumor tissue, in patients with breast cancer arising during or after treatment with platinum-based chemotherapy or PARP-inhibitors for ovarian cancer.
1 secondary outcome
Ovarian somatic mutations
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for BRCA-Associated Breast Carcinoma
Active, not recruiting
Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in BRCA-associated Triple-negative Locally Advanced Breast Cancer
Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation
Active, not recruitingPhase 1
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer
Breast Cancer
Recruiting
Evaluating an Evidence-Based Family History Screening Program Adapted to Increase Reach and Uptake of Screening for BRCA-Associated Cancers in Rural Public Health Clinics
Breast Cancer, Ovarian Cancer
Active, not recruitingPhase 1/2
Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer, Breast Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA-Associated Breast Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 6 inclusion and 2 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 Mar 2023. 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.
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?
Contact IDA PARIS, MD (+39 0630156493, ida.paris@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast somatic mutations (time frame: 15 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 Mar 2023.