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

NCT07195227 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Camizestrant

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

DRUG

Ribociclib

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).

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-02-29
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195227 on ClinicalTrials.gov