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New treatment option for Breast Cancer
Official title NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
ClinicalTrials.gov ID: NCT06259929
What this study is testing
What is Abemaciclib 150 MG + Giredestrant 30 MG?
Abemaciclib 150 MG + Giredestrant 30 MG is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Documented bilateral oophorectomy (≥ 14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline);
You likely can't join if
- 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)...
- Participants who have active cardiac disease or history of cardiac dysfunction, including any of the following:
See the full eligibility criteria
Who can 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...
- 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;
- 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...
- 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...
- 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 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.
What rules you out
- 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...
- Participants who have active cardiac disease or history of cardiac dysfunction, including any of the following:
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
The study team makes the final eligibility decision.
Where it's taking place
- Catania, Catania, Italy
- Genova, Genova, Italy
- Naples, Napoli, Italy
- Padova, Padova, Italy
- Aviano, PN, Italy
- Roma, Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Catania, Catania, Italy; Genova, Genova, Italy; Naples, Napoli, Italy; Padova, Padova, Italy; Aviano, PN, Italy; Roma, Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.