Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer

Sponsor
MedSIR
Study ID
NCT07195227
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Camizestrant — DRUG
    Next-generation oral SERD molecule that is intended for the treatment of women and men with ER+ breast cancer. In addition to degradation of ERα, camizestrant also acts as a pure ER antagonist
  • Ribociclib — DRUG
    Selective inhibitor of CDK 4 and 6, with 50% inhibition (IC50) values of 0.01 μM (4.3 ng/ml) and 0.039 μM (16.9 ng/ml) in biochemical assays, respectively. These kinases are activated by binding to D-cyclins and are crucial to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates the cell cycle by phosphorylating the retinoblastoma protein (pRb).

Study Details

This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS). The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

Key Dates

Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm A: Camizestrant and Ribociclib
    Patients will receive Camizestrant (75 mg, oral, every day on each day of the 28-day cycle) and Ribociclib (600 mg, oral, every day, on day 1 to 21 of each 28-day cycle)
  • No Intervention: Control Arm B: Historical Arm
    The clinical Study comparator will be a historical control arm containing data from all or some of the following clinical trials: MONALEESA-2, MONALEESA-3, MONALEESA-7, CompLEEment-1, and RIBECCA.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 28 months ]

Central Contacts

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