Breast CancerINTENTNCT05846997
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
An observational study of Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Liquid biopsy and imaging
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2018to 24 Feb 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Histological Diagnosis of Infiltrating Breast Cancer
Who may be able to join
- Age ≥ 18 years
- Histological Diagnosis of Infiltrating Breast Cancer.
- The presence of measurable mammary lesions;
- The presence of metabolically active mammary lesions;
- Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1;
- Compliance with periodic blood withdrawal;
Show all 9Show fewer
- Compliance with periodic PET/CT and RMN imaging;
- Adequate clinical and laboratory test results for undertaking neoadjuvant chemotherapy and surgery;
- Written informed consent.
Who cannot join
- The presence of contraindications for the execution of RMN and PET-TC;
- Presence of metastatic disease;
- Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin;
- Uncontrolled active infections;
- Insufficient patient compliance;
- Absence of signed informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081
Milena Nicoloso, MD, +39 0434659119, mnicoloso@cro.it
Silvia Bolzonello, MD, +39 0434659255, silvia.bolzonello@cro.it
About this study
The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy
Read the detailed description
This is a single arm prospective, monocentric, open, experimental pilot study. The response to NAC in breast cancer is extremely heterogeneous. The study and the identification of factors that can predict the response to treatment is therefore a priority, constituting a relevant "clinical unmet need".Modern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to NAC toward the definition of more personalized therapies.The prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the Regional and National Health system. This study will also provide the patients, their familiar and all the stakeholders involved in the cure of Breast Cancer new important information regarding the management of breast cancer patients.This is a non-interventional study; therefore, the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients' based on the type and stage of disease and the patients' performance status.Currently, the NAC regimens commonly used at CRO-Aviano for NAC are Epirubicine 90 mg/mq + Ciclophosphamide 600 mg/mq d1 q21 or q14 (EC)(dose dense) followed by weekly Paclitaxel 80 mg/mq for a total of 12 administrations. Occasionally, due to patients and tumor features only weekly Paclitaxel is used, and usually in this case up to 24 administrations may be given. Only in the case of HER2 positive BC trastuzumab 2 mg/kg is added to weekly Paclitaxel. Given the low response rate of hormone-based neoadjuvant therapy, only in rare cases (e.g. patients not amenable of surgery due to comorbidities), this approach is used.
- Conditions
- Breast Cancer
- Being tested
- Liquid biopsy and imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsy and imagingDiagnostic test
Liquid biopsy and imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
- Determine if a PET SUV decrease ≥ 50% after two cycles of therapy respect to the basal value will predict the pCR predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
- Determine if a cfDNA variation ≥ 25% of the basal value after two cycles of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy
Measured: from start of therapy until first documented progression, assessed up to 12 months
Secondary outcomes (6)
Determine if the basal number of CTC and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Determine if the basal number of CTC and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy pCR of breast cancer patients treated with neo-adjuvant therapy;
Determine if the basal Metabolomics spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal Cytokines serum levels and/or their variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Determine if the basal Cytokines serum levels and/or their variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Determine if a the basal Immune proficiency will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Determine if a variation in T cell sub-populations will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Measured: from start of therapy until first documented progression, assessed up to 12 months
Evaluate over time Relapse Free Survival (RFS) and correlate with micro-invasive parameters from primary and/or secondary objectives.
Evaluate over time Relapse Free Survival (RFS) and correlate with micro-invasive parameters from primary and/or secondary objectives.
Measured: from start of therapy until first documented relapse, assessed 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 posted6 May 2023
- Study start20 Jun 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion24 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milena Nicoloso, MD, Principal investigator, Centro di Riferimento Oncologico - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846997
- Sponsor's protocol ID
- CRO-2018-10
- Acronym
- INTENT
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
- ClinicalTrials.gov ID
- NCT05846997
- Acronym / sponsor ID
- INTENT / CRO-2018-10
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 24 Feb 2025 (estimated)
- First posted
- 6 May 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.
The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy
Detailed description
This is a single arm prospective, monocentric, open, experimental pilot study. The response to NAC in breast cancer is extremely heterogeneous. The study and the identification of factors that can predict the response to treatment is therefore a priority, constituting a relevant "clinical unmet need".Modern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to NAC toward the definition of more personalized therapies.The prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the Regional and National Health system. This study will also provide the patients, their familiar and all the stakeholders involved in the cure of Breast Cancer new important information regarding the management of breast cancer patients.This is a non-interventional study; therefore, the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients' based on the type and stage of disease and the patients' performance status.Currently, the NAC regimens commonly used at CRO-Aviano for NAC are Epirubicine 90 mg/mq + Ciclophosphamide 600 mg/mq d1 q21 or q14 (EC)(dose dense) followed by weekly Paclitaxel 80 mg/mq for a total of 12 administrations. Occasionally, due to patients and tumor features only weekly Paclitaxel is used, and usually in this case up to 24 administrations may be given. Only in the case of HER2 positive BC trastuzumab 2 mg/kg is added to weekly Paclitaxel. Given the low response rate of hormone-based neoadjuvant therapy, only in rare cases (e.g. patients not amenable of surgery due to comorbidities), this approach is used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Histological Diagnosis of Infiltrating Breast Cancer
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Histological Diagnosis of Infiltrating Breast Cancer.
- The presence of measurable mammary lesions;
- The presence of metabolically active mammary lesions;
- Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1;
Key exclusion criteria (6 listed)
- The presence of contraindications for the execution of RMN and PET-TC;
- Presence of metastatic disease;
- Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin;
- Uncontrolled active infections;
- Insufficient patient compliance;
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 |
|---|---|---|
| Liquid biopsy and imagingLiquid biopsy and imaging | Diagnostic test | – |
Primary outcome
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
Time frame: from start of therapy until first documented progression, assessed up to 12 months
1. Determine if a PET SUV decrease ≥ 50% after two cycles of therapy respect to the basal value will predict the pCR predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.
Time frame: from start of therapy until first documented progression, assessed up to 12 months
2. Determine if a cfDNA variation ≥ 25% of the basal value after two cycles of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy
6 secondary outcomes
Determine if the basal number of CTC and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Time frame: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy pCR of breast cancer patients treated with neo-adjuvant therapy;
Time frame: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Time frame: from start of therapy until first documented progression, assessed up to 12 months
Determine if the basal Cytokines serum levels and/or their variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Time frame: from start of therapy until first documented progression, assessed up to 12 months
Determine if a the basal Immune proficiency will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;
Time frame: from start of therapy until first documented progression, assessed up to 12 months
Evaluate over time Relapse Free Survival (RFS) and correlate with micro-invasive parameters from primary and/or secondary objectives.
Time frame: from start of therapy until first documented relapse, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
Milena Nicoloso, MD principal investigator
Centro di Riferimento Oncologico - Aviano
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 Breast Cancer, run by Centro di Riferimento Oncologico - Aviano 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 9 inclusion and 6 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 6 May 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 Milena Nicoloso, MD (+39 0434659119, mnicoloso@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy. (time frame: from start of therapy until first documented progression, assessed up to 12 months). The study lists 2 primary outcomes in all. 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 6 May 2023.