NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

Sponsor
Fondazione Oncotech
Study ID
NCT06259929
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib 150 MG + Giredestrant 30 MG — DRUG
    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 Details

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

Key Dates

Start date
Jan 27, 2025
Status verified
Feb 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with ER-positive, HER2-negative Early breast cancer
    Abemaciclib 150 mg oral twice daily (BID) and giredestrant 30 mg oral once daily (OD) on Days 1-28.

Primary Outcome Measure

Efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate [ Time Frame: Week 2 ]

Central Contacts

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