Breast NeoplasmsPhase 2TRINACRIANCT02416427
Targeting the Hippo Transducer TAZ in Breast Cancer With Statins
A Phase 2 study testing Atorvastatin in people with Breast Neoplasms, run by Regina Elena Cancer Institute.
Trial summary
This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Female aged >18 years and <75 years at the time of the enrolment
- Histologically confirmed Breast Cancer (BC) independently on the intrinsic subtype
- Stage I-IIa BC patients candidate for elective surgery
- BC expressing Ki-67 ≥ 15% and TAZ > 10% in diagnostic core biopsies
- Adequate baseline organ function
- Negative pregnancy test
Who cannot join
- Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
- Administration of an investigational drug prior to enrolment
- History of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
- Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
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- Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
- Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs
- Current or recent therapy with glucose-lowering drugs for diabetes
- Current or recent therapy with strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, itraconazole) given potential interactions with atorvastatin
- Current or recent therapy with gemfibrozil or other fibrates given potential interactions with atorvastatin.
- Patients who are pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Randomized, Non-comparative, Pre-surgical Study of Atorvastatin or Observation in Ki-67 Positive, TAZ-expressing Early Breast Cancer Patients (TRINACRIA Trial)
This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.
- Conditions
- Breast Neoplasms
- Being tested
- Atorvastatin
- Keywords
- Atorvastatin, TAZ, Hippo pathway, ki67
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin will be administered at 80 mg/day for 3 weeks in the time window between diagnostic biopsy and curative surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Atorvastatin 80 mg/day for 3 weeks Receives: Drug: Atorvastatin |
| Arm B | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki-67 reduction below the 15% (marker response).
Measured: 4 weeks
Secondary outcomes (2)
• Decreased TAZ expression
Reduced TAZ expression evaluated by IHC when comparing pre- and post-treatment samples. Staining intensity will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong). The final score will be obtained by considering staining intensity, percentage of expressing cells, and localization (nuclear versus cytoplasmic)
Measured: 4 weeks
Pathway inhibition
Decreased expression of TAZ targets (AXL and CTGF) and Atorvastatin target (HMGCoAR) evaluated by IHC when comparing pre- and post-treatment samples. Staining intensity for all the molecular endpoints analyzed will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marcello Maugeri-Saccà, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416427
- Sponsor's protocol ID
- 637/15
- Acronym
- TRINACRIA
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Non-comparative, Pre-surgical Study of Atorvastatin or Observation in Ki-67 Positive, TAZ-expressing Early Breast Cancer Patients (TRINACRIA Trial)
- ClinicalTrials.gov ID
- NCT02416427
- Acronym / sponsor ID
- TRINACRIA / 637/15
- Conditions
- Breast Neoplasms
- Keywords
- Atorvastatin, TAZ, Hippo pathway, ki67
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Apr 2015 (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.
This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AtorvastatinAtorvastatin 80 mg/day for 3 weeks |
| Arm B | No intervention | –Observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent
- Female aged >18 years and <75 years at the time of the enrolment
- Histologically confirmed Breast Cancer (BC) independently on the intrinsic subtype
- Stage I-IIa BC patients candidate for elective surgery
- BC expressing Ki-67 ≥ 15% and TAZ > 10% in diagnostic core biopsies
Key exclusion criteria (12 listed)
- Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
- Administration of an investigational drug prior to enrolment
- History of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
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 |
|---|---|---|
| AtorvastatinAtorvastatin will be administered at 80 mg/day for 3 weeks in the time window between diagnostic biopsy and curative surgery | Drug | Arm A |
Primary outcome
Ki-67 reduction below the 15% (marker response).
Time frame: 4 weeks
2 secondary outcomes
• Decreased TAZ expression
Time frame: 4 weeks
Pathway inhibition
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Breast Neoplasms, run by Regina Elena Cancer Institute.
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 7 inclusion and 12 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Marcello Maugeri Saccà, MD (+39065266 ext. 2724, maugeri@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki-67 reduction below the 15% (marker response). (time frame: 4 weeks). 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 15 Apr 2015.