Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedSIR
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be capable of understanding the purpose of the Study and have signed the written informed consent form (ICF) prior to beginning specific protocol procedures.
Female or male patients ≥ 18 years of age at the time of signing ICF.
Pre- or peri-menopausal women or men. are eligible if treated with a Luteinizing hormone-releasing hormone (LHRH) analogue. Treatment with a LHRH is recommended for at least 28 days prior to study treatment; if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically prior to Study enrollment.
Cessation of menses for at least 12 consecutive months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Disqualifiers
Formal contraindication to endocrine therapy defined as visceral crisis and/or rapidly or symptomatic progressive visceral disease.
Current participation in another therapeutic clinical trial.
Has previously been treated with any SERD, including camizestrant, experimental ETs or fulvestrant.
Prior systemic therapy for advanced disease.
Trial design
Design model
Single group
Treatments tested in this trial
Camizestrant
DrugNext-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
DrugSelective 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).
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Experimental Arm A: Camizestrant and RibociclibExperimental treatment 2 interventions
Group B: Control Arm B: Historical ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
PFS, defined as the time from the date of the first dose until the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Time frame
Up to 28 monthsSecondary outcomes
1
Overall Response Rate (ORR)
ORR, defined as the rate of patients with a Best Overall Response (BOR) of complete response or partial response, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Time frame
Up to 28 months2
Clinical Benefit Rate (CBR)
CBR, defined as the rate of patients with objective response (complete or partial response), or stable disease for at least 24 weeks, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Time frame
up to 28 months3
Time to Response (TTR)
TTR, defined as the time from the date of the first dose until the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a complete or partial response, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Time frame
Up to 28 months4
Duration of Response (DoR)
DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Time frame
Up to 28 months Source ClinicalTrials.gov