Actively Recruiting
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
Led by Fondazione Oncotech · Updated on 2025-02-18
51
Participants Needed
8
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients willing and able to give written informed consent
- Women 18 years of age or older
- Postmenopausal women defined by 12 months of amenorrhea and appropriate hormone levels or documented bilateral oophorectomy at least 14 days before treatment
- Patients with early breast cancer tumors 1.0 cm or larger confirmed by ultrasound
- Confirmed ER-positive disease with tumor ER ≥10% by immunohistochemistry according to ASCO/CAP guidelines
- Confirmed HER2-negative disease according to ASCO/CAP 2023 guidelines
- Patients with multifocal or multicentric breast cancer with at least one lesion ≥1.0 cm confirmed to be ER-positive and HER2-negative
- No previous treatment for breast cancer including chemotherapy, hormone therapy, surgery, or radiotherapy
- Patients suitable for endocrine therapy as judged by physician
- Ki67 score ≥10% confirmed locally and centrally
- Patients eligible for primary surgery
- ECOG performance status of 0 or 1
- Adequate bone marrow, coagulation, and organ function as defined by specified blood counts and biochemical parameters
- Patients able to swallow oral medications
You will not qualify if you...
- Patients with bilateral invasive breast cancer
- Patients with metastatic breast cancer (except local spread to axillary lymph nodes)
- Patients with inflammatory breast cancer
- Non postmenopausal women
- Patients who have had prior systemic or local breast cancer treatments including aromatase inhibitors, tamoxifen, selective estrogen receptor down regulators, or CDK4/6 inhibitors
- Patients with active cardiac disease or history of significant cardiac dysfunction or arrhythmias
- Patients with clinically significant liver disease consistent with Child-Pugh Class B or C
- History of invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or other malignancy within 5 years prior to screening
- Patients with bleeding disorders, coagulopathy, or thromboembolism
- Concurrent treatment with exogenous reproductive hormone therapy
- Active systemic bacterial, fungal, or certain viral infections
- Serious uncontrolled medical conditions that would interfere with participation
- Known allergy or hypersensitivity to study drugs or their components
- History of non-compliance to medical regimens
- Refusal to perform liquid and tissue biopsy
- Inability or unwillingness to comply with study protocol
- Major surgery within 14 days prior to screening
- Pregnant or breastfeeding women
- Participation in other experimental treatment trials within 30 days or 5 half-lives prior to study treatment
- Known HIV positive status or acquired immunodeficiency syndrome
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Humanitas Istituto Clinico Catanese
Catania, Catania, Italy, 95045
Not Yet Recruiting
2
IRCCS Ospedale Policlinico San Martino
Genova, Genova, Italy, 16132
Not Yet Recruiting
3
AOU Federico II
Naples, Napoli, Italy, 80131
Not Yet Recruiting
4
Istituto Nazionale Tumori "G. Pascale"
Naples, Napoli, Italy, 80131
Actively Recruiting
5
Istituto Oncologico Veneto IRCCS
Padova, Padova, Italy, 35128
Not Yet Recruiting
6
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, PN, Italy, 33081
Not Yet Recruiting
7
Fondazione Universitaria Policlinico Gemelli IRCCS
Roma, Roma, Italy, 00168
Not Yet Recruiting
8
Ospedale Fatebenefratelli - Isola Tiberina
Roma, Roma, Italy, 00186
Not Yet Recruiting
Research Team
M
Michelino De Laurentiis, MD
CONTACT
C
Claudia Von Arx, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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