Breast CancerPhase 2Neo-AGILENCT06259929
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
A Phase 2 study testing Abemaciclib 150 MG + Giredestrant 30 MG in people with Breast Cancer, run by Fondazione Oncotech at 8 sites in Italy.
Trial summary
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). 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?
- Abemaciclib 150 MG + Giredestrant 30 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 8 sitesItaly
- Study dates
- 27 Jan 2025to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Female patients willing and able to give written informed consent;
- Women≥18 years of age;
- Postmenopausal women, as defined by at least one of the following criteria:
- ≥12 months of amenorrhea without an alternate medical cause plus follicle-stimulating hormone (FSH) and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone agonist or antagonist. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
- Documented bilateral oophorectomy (≥ 14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline);
- Patients with cT1c (≥1.0 cm)-cT4a-c BC at presentation; a-c primary tumor must be ≥ 1.0 cm in longest diameter by ultrasound;
Show all 23Show fewer
- Confirmed ER+ disease by local testing on primary disease specimen: tumor must be ER ≥ 10% defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing;
- Confirmed HER2- disease by local testing on primary disease specimen: tumor must be HER2- according to ASCO/CAP 2023 guidelines for HER2 testing;
- Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathologic criteria for ER positivity and HER2 negativity.
- No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy;
- Patients considered appropriate for endocrine therapy according to physician judgment;
- Ki67 score ≥10% analyzed locally and centrally confirmed. Ki67 will be analyzed locally at the time of inclusion. Patients with basal Ki67≥20% will be assessed locally and centrally confirmed retrospectively and patients with 10-19% will be assessed centrally before inclusion.
- Patients with breast cancer eligible for primary surgery;
- Eastern Cooperative Oncology Group (ECOG) performance status≤1;
- Adequate bone marrow and coagulation and adequate organ function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
- Platelets count ≥100x 109/L;
- Haemoglobin ≥9 g/dL (90 g/L);
- Serum creatinine≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance≥60 ml/min as calculated using the standard method for the institution;
- Total serum bilirubin ≤1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits could be included);
- AST and/or ALT ≤3 x ULN;
- Alkaline phosphatase ≤2.5 x ULN;
- Patients able to swallow oral medications.
Who cannot join
- Patients with bilateral invasive BC;
- Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1_cN2a);
- Patients with inflammatory BC;
- Non post-menopausal patients;
- Patients having received previous systemic or local treatment for BC, in particular history of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors;
- Participants who have active cardiac disease or history of cardiac dysfunction, including any of the following:
Show all 28Show fewer
- History (within 2 years of screening) or presence of idiopathic bradycardia or resting heart rate < 50 beats per minute at screening
- History of angina pectoris or symptomatic coronary heart disease within 12 months prior to randomization
- History of documented congestive heart failure (New York Heart Association Class III or IV) or cardiomyopathy
- QT interval corrected through use of Fridericia's formula >470 ms for women > 450 ms for men based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes
- Presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or sick sinus syndrome o Participants with first-degree heart block may be considered for inclusion following consultation with a cardiologist and determination that no additional cardiac risks are present.
- Participants with pacemakers to treat more severe heart blocks and other arrhythmias are permitted.
- Patients with history of well-controlled atrial fibrillation are eligible.
- History (within 12 months) or presence of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as significant structural heart disease (e.g., severe left ventricular systolic dysfunction, restrictive cardiomyopathy, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, moderate-to-severe valve disease), or family history of long QT syndrome) o Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia) should be corrected prior to enrollment.
- Patients with known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis;
- Patients with history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ and other malignancy within 5 years prior to screening;
- Patients with documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism;
- Patients on concurrent treatment with exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate);
- Patients with active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive];
- Patients with serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study, e.g. interstitial lung disease (ILD), severe dyspnoea at rest requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance <30 ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea);
- Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients;
- Patients with history of non-compliance to medical regimens;
- Patients refusing to perform liquid and tissue biopsy;
- Patients unwilling to or unable to comply with the protocol;
- Patients having had major surgery within 14 days prior to screening;
- Pregnant or lactating females prior to treatment;
- Patients having received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to initiation of study treatment, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study;
- Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Not yet recruiting
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, PN, 33081
Fabio Puglisi, MD, 0434659253, fabio.puglisi@cro.it
- Not yet recruiting
Humanitas Istituto Clinico Catanese
Catania, Catania, 95045
Paolo Vigneri, MD, 0957339000, vigneri.p@unict.it;vigneripaolo@gmail.com
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino
Genova, Genova, 16132
Lucia Del Mastro, MD, 010.5558904 - 8908, lucia.delmastro@hsanmartino.it
- Not yet recruiting
AOU Federico II
Naples, Napoli, 80131
Grazia Arpino, MD, 0817463772/7251, grazia.arpino@unina.it
- Recruiting
Istituto Nazionale Tumori "G. Pascale"
Naples, Napoli, 80131
Michelino De Laurentiis, MD, 08117770442, m.delaurentiis@istitutotumori.na.it;delauren@breastunit.org
- Not yet recruiting
Istituto Oncologico Veneto IRCCS
Padova, Padova, 35128
Valentina Guarneri, MD, 0498215291, valentina.guarneri@unipd.it
- Not yet recruiting
Fondazione Universitaria Policlinico Gemelli IRCCS
Roma, Roma, 00168
Alessandra Fabi, MD, 0630157337, alessandra.fabi@policlinicogemelli.it
- Not yet recruiting
Ospedale Fatebenefratelli - Isola Tiberina
Roma, Roma, 00186
Francesco Cognetti, MD, f.cognetti1@gmail.com
About this study
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC).
Primary objective:
Read more
● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2.
Secondary objectives:
- To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2
- To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response;
- To evaluate the safety of abemaciclib and giredestrant.
Exploratory objectives:
- To evaluate the mechanisms of response and resistance to therapy;
- To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction;
- To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib
Read the detailed description
This is a phase II, multicentre, single-arm neoadjuvant study in post- menopausal women with ER-positive and HER2-previously untreated early BC. The trial will include approximately 10 sites in Italy.
The study plan will include a maximum 28-day screening period prior to start treatment. During the 6 cycles of the on-study intervention period, participants will return to the clinic every 2 weeks (14 ± 3 days) for the first 2 cycles, and then on Day 1 of the subsequent 4 cycles.
Surgery should be performed as soon as possible after at least 7 days, from the last dose of abemaciclib and giredestrant, and no later than 30 days.
During the short-term follow-up, participants should return for an in-clinic visit 28 days (± 5 days) after surgery. After the short-term follow-up visit, all participants will enter the long-term follow-up period, which will begin the day after the short-term follow-up visit and will continue up to Year1. Visits during the long-term follow-up visits should occur approximately every 3 months for a total of one year. For participants who are unable to attend the required clinic visits, long-term follow-up visits can take place as a phone visit.
Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy in ER+ and HER2- early BC. For each patient enrolled in the present study, blood samples (mandatory) and tumor biopsies (mandatory) are required and collected at entry in the study, following 14 days and 12 weeks of treatment, and prior to or during surgery. Blood samples are also required to be collected at the short follow up visit, at the end of the long follow-up period after on year (± 28 days) from the last short follow-up visit and at disease progression (suggested but not mandatory).
- Conditions
- Breast Cancer
- Being tested
- Abemaciclib 150 MG + Giredestrant 30 MG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abemaciclib 150 MG + Giredestrant 30 MGDrug
Enrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with ER-positive, HER2-negative Early breast cancer | Experimental | Abemaciclib 150 mg oral twice daily (BID) and giredestrant 30 mg oral once daily (OD) on Days 1-28. Receives: Drug: Abemaciclib 150 MG + Giredestrant 30 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate
CCCA rate, defined as the proportion of patients with centrally assessed Ki67 scores ≤ 2.7% in stained biopsies
Measured: Week 2
Secondary outcomes (4)
Efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression
Percent change in Ki67 expression
Measured: from baseline to Week 2 and at surgery (after the last dose of abemaciclib and giredestrant)
Efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score change, clinical and radiological tumor response
ROR score change
Measured: from baseline to Week 2 and at surgery (after the last dose of abemaciclib and giredestrant)
Clinical and radiologic objective responses rate
Clinical and radiologic (magnetic resonance imaging [MRI]) objective responses measured according to the Recist Criteria 1.1
Measured: Screening, Week 2, Week 12, Week 24 then through follow-up completion (up to a year)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Treatment-Emergent adverse events evaluation measured as per CTCAE v5.0 criteria
Measured: Screening, during the treatment/surgery then through follow-up completion (up to a year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start27 Jan 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelino De Laurentiis, MD, Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259929
- Sponsor's protocol ID
- GIM31-Neo-AGILE
- Acronym
- Neo-AGILE
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06259929
- Acronym / sponsor ID
- Neo-AGILE / GIM31-Neo-AGILE
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fondazione OncotechUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Feb 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 objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC).
Primary objective:
● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2.
Secondary objectives:
- To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2
- To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response;
- To evaluate the safety of abemaciclib and giredestrant.
Exploratory objectives:
- To evaluate the mechanisms of response and resistance to therapy;
- To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction;
- To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib
Detailed description
This is a phase II, multicentre, single-arm neoadjuvant study in post- menopausal women with ER-positive and HER2-previously untreated early BC. The trial will include approximately 10 sites in Italy.
The study plan will include a maximum 28-day screening period prior to start treatment. During the 6 cycles of the on-study intervention period, participants will return to the clinic every 2 weeks (14 ± 3 days) for the first 2 cycles, and then on Day 1 of the subsequent 4 cycles.
Surgery should be performed as soon as possible after at least 7 days, from the last dose of abemaciclib and giredestrant, and no later than 30 days.
During the short-term follow-up, participants should return for an in-clinic visit 28 days (± 5 days) after surgery. After the short-term follow-up visit, all participants will enter the long-term follow-up period, which will begin the day after the short-term follow-up visit and will continue up to Year1. Visits during the long-term follow-up visits should occur approximately every 3 months for a total of one year. For participants who are unable to attend the required clinic visits, long-term follow-up visits can take place as a phone visit.
Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy in ER+ and HER2- early BC. For each patient enrolled in the present study, blood samples (mandatory) and tumor biopsies (mandatory) are required and collected at entry in the study, following 14 days and 12 weeks of treatment, and prior to or during surgery. Blood samples are also required to be collected at the short follow up visit, at the end of the long follow-up period after on year (± 28 days) from the last short follow-up visit and at disease progression (suggested but not mandatory).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ER-positive, HER2-negative Early breast cancer | Experimental | Drug: Abemaciclib 150 MG + Giredestrant 30 MGAbemaciclib 150 mg oral twice daily (BID) and giredestrant 30 mg oral once daily (OD) on Days 1-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Female patients willing and able to give written informed consent;
- Women≥18 years of age;
- Postmenopausal women, as defined by at least one of the following criteria:
- Patients with cT1c (≥1.0 cm)-cT4a-c BC at presentation; a-c primary tumor must be ≥ 1.0 cm in longest diameter by ultrasound;
- Confirmed ER+ disease by local testing on primary disease specimen: tumor must be ER ≥ 10% defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing;
Key exclusion criteria (28 listed)
- Patients with bilateral invasive BC;
- Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1_cN2a);
- Patients with inflammatory BC;
- Non post-menopausal patients;
- Patients having received previous systemic or local treatment for BC, in particular history of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors;
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 |
|---|---|---|
| Abemaciclib 150 MG + Giredestrant 30 MGEnrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery | Drug | Patients with ER-positive, HER2-negative Early breast cancer |
Primary outcome
Efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate
Time frame: Week 2
CCCA rate, defined as the proportion of patients with centrally assessed Ki67 scores ≤ 2.7% in stained biopsies
4 secondary outcomes
Efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression
Time frame: from baseline to Week 2 and at surgery (after the last dose of abemaciclib and giredestrant)
Efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score change, clinical and radiological tumor response
Time frame: from baseline to Week 2 and at surgery (after the last dose of abemaciclib and giredestrant)
Clinical and radiologic objective responses rate
Time frame: Screening, Week 2, Week 12, Week 24 then through follow-up completion (up to a year)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Time frame: Screening, during the treatment/surgery then through follow-up completion (up to a year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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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.
Michelino De Laurentiis, MD principal investigator
National Cancer Institute, Naples
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib 150 MG + Giredestrant 30 MG in people with Breast Cancer, run by Fondazione Oncotech at 8 sites 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 23 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelino De Laurentiis, MD (08117770442, m.delaurentiis@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate (time frame: Week 2). 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 18 Feb 2025.