Breast CancerBC-P1-2013NCT02950207
Prospective Observational Study of Antitumor Activity Correlation Between Hormonal Therapy and Expression miRNA100
An observational study of Breast Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
Mono-centric, observational, prospective study, designed for pts with diagnosis of hormone-positive breast cancer to evaluate the correlation between the response to hormonal treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of patients Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- miRNA
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2019
- 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: post menopausal hormone-positive breast cancer patients
Who may be able to join
- Ability to provide written informed consent
- Age greater than 18 years
- histological diagnosis of invasive carcinoma of the breast
- X-ray evidence (mammography and / or ultrasound) strongly suggestive for the presence of invasive breast cancer (BIRADS 4c or BIRADS 5) of greater than 15mm diameter.
- Carcinoma stage I (if diameter> 15 mm) or II, unresectable, or
- Carcinoma in stage II or III, operable as a result of presurgical therapy, or
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- Carcinoma in IV debut stage, asymptomatic, with primary operable breast cancer, or as a result of presurgical therapy
- Positivity for the estrogen receptor and / or to the progestin defined as the expression of one or both hormone receptors in ≥10% of tumor cells
- Negativity for HER2
- Cell proliferation, defined as the percentage of Ki67 positive tumor cells,> 5% (corresponding to a value of 1.79 after log-normal transformation)
- Postmenopausal status
- Ability to take an oral therapy, in the absence of malabsorption syndrome known, previous stomach surgery or the small intestine
- Ability to perform the staging examinations and screening provided for in the
- Protocol
- Eastern Cooperative Oncology Group (ECOG) = 0
- The patients will have a normal bone marrow function, liver and kidney
Who cannot join
- Previous treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.
- Other cancers diagnosed in the last five years, with the exception of basal cell or squamous cell carcinoma of the skin, melanoma in situ or cervical cancer in situ.
- Premenopausal
- Known hypersensitivity to letrozole or to any of its excipients (for example: women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or mal absorption of glucose / galactose).
- Evidence of a severe and poorly controlled systemic disease affecting the lung, heart, liver, kidney that may compromise adherence to treatment or an extended follow-up.
- Inflammatory bowel disease not controlled (eg Crohn's disease, ulcerative colitis).
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- Active infection and / or inadequately controlled.
- Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
- Breast cancer triple negative, or negative for both HER2 overexpression for the expression of hormone receptors.
Trial locations and contacts
1 site in 1 country.
Filippo Montemurro, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, 10060
Annamaria Nuzzo, PhD, +390119933398, annamaria.nuzzo@ircc.it
About this study
Official title: Prospective Observational Study to Evaluate the Correlation Between Antitumor Activity of Hormone Therapy and the Expression of Micro-RNA (miRNA) 100
Mono-centric, observational, prospective study, designed for pts with diagnosis of hormone-positive breast cancer to evaluate the correlation between the response to hormonal treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of patients
Read the detailed description
The potential role of miRNAs will be studied as a predictor of hormone sensitivity in hormone-positive breast carcinomas. The miRNA100 obtained on biopsy will be compared with the expression levels of those obtained from the surgically removed tumor, in order to assess the possible modulation of miRNA100 following hormonal treatment.
- Conditions
- Breast Cancer
- Being tested
- miRNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNAGenetic
miRNA extraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy
the natural logarithm value of Ki67 <1.0 defines the proliferative response to treatment. Response evaluation will be performed by measuring the reduction of Ki67 as a result of hormonal treatment according to a schedule defined on the basis of the stage of disease: patients with immediate operable cancer will be valued at the time of surgery (about 3 weeks).
candidate patients to neoadjuvant hormone therapy and patients with stage 4 debut in hormonal therapy in advanced therapy (evaluation during the third week of starting treatment)
Measured: 42 months or until disease progression
Secondary outcomes (1)
Evaluation of Tolerability
The frequency and severity of adverse events will be evaluated based on the NCI-CTCAE v 4.0 criteria
Measured: 42 months or until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filippo Montemurro, MD, Principal investigator, FPO-IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950207
- Sponsor's protocol ID
- BC-P1-2013
- Acronym
- BC-P1-2013
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Correlation Between Antitumor Activity of Hormone Therapy and the Expression of Micro-RNA (miRNA) 100
- ClinicalTrials.gov ID
- NCT02950207
- Acronym / sponsor ID
- BC-P1-2013 / BC-P1-2013
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Mono-centric, observational, prospective study, designed for pts with diagnosis of hormone-positive breast cancer to evaluate the correlation between the response to hormonal treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of patients
Detailed description
The potential role of miRNAs will be studied as a predictor of hormone sensitivity in hormone-positive breast carcinomas. The miRNA100 obtained on biopsy will be compared with the expression levels of those obtained from the surgically removed tumor, in order to assess the possible modulation of miRNA100 following hormonal treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post menopausal hormone-positive breast cancer patients
Key inclusion criteria (16 listed)
- Ability to provide written informed consent
- Age greater than 18 years
- histological diagnosis of invasive carcinoma of the breast
- X-ray evidence (mammography and / or ultrasound) strongly suggestive for the presence of invasive breast cancer (BIRADS 4c or BIRADS 5) of greater than 15mm diameter.
- Carcinoma stage I (if diameter> 15 mm) or II, unresectable, or
Key exclusion criteria (9 listed)
- Previous treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.
- Other cancers diagnosed in the last five years, with the exception of basal cell or squamous cell carcinoma of the skin, melanoma in situ or cervical cancer in situ.
- Premenopausal
- Known hypersensitivity to letrozole or to any of its excipients (for example: women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or mal absorption of glucose / galactose).
- Evidence of a severe and poorly controlled systemic disease affecting the lung, heart, liver, kidney that may compromise adherence to treatment or an extended follow-up.
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 |
|---|---|---|
| miRNAmiRNA extraction | Genetic | – |
Primary outcome
Evaluation of the efficacy
Time frame: 42 months or until disease progression
the natural logarithm value of Ki67 <1.0 defines the proliferative response to treatment. Response evaluation will be performed by measuring the reduction of Ki67 as a result of hormonal treatment according to a schedule defined on the basis of the stage of disease: patients with immediate operable cancer will be valued at the time of surgery (about 3 weeks). candidate patients to neoadjuvant hormone therapy and patients with stage 4 debut in hormonal therapy in advanced therapy (evaluation during the third week of starting treatment)
1 secondary outcome
Evaluation of Tolerability
Time frame: 42 months or until disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Filippo Montemurro, MD contact
Filippo Montemurro, MD principal investigator
FPO-IRCCS
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 Fondazione del Piemonte per l'Oncologia 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 16 inclusion and 9 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 3 Nov 2016. 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 Annamaria Nuzzo, PhD (+390119933398, annamaria.nuzzo@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy (time frame: 42 months or until disease progression). 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 3 Nov 2016.