Health Trials

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

ConditionER-Positive HER2-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving signed informed consent.

Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.

Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.

Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.

Disqualifiers

Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.

No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.

Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.

Persistent treatment-induced non-haematological toxicities (CTCAE Grade > 2).

Trial design

Design model

Single group

Treatments tested in this trial

  • Camizestrant

    Drug

    Patients will receive the standard dose of camizestrant once daily as oral tablets

  • Ribociclib

    Drug

    Patients will receive the standard dose of ribociclib once daily as oral tablets

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Camizestrant and RibociclibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)

TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death. The primary measure of interest is the TTNT event-free rate at 2 years.

Time frame
Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.

Secondary outcomes

1

Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)

TTD is defined as time from the date of the first administration of study treatment to the earliest date of camizestrant treatment discontinuation or death. The primary measure of interest is the TTD event-free rate at 2 years.

Time frame
Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment
2

Efficacy of camizestrant and ribociclib by progression free survival (PFS)

PFS is defined as time from first dose of study treatment until progression per RECIST 1.1 as assessed by investigator or death due to any cause. The primary measures of interest are the PFS event-free rates at 1 and 2 years.

Time frame
Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.
3

CTCAE grade ≥ 3 associated with camizestrant and ribociclib within first 6 months of study treatment

Incidence of Grade \>=3 CTCAEs associated with Camizestrant and/or Ribo within first 6 months of receiving study treatment.

Time frame
Following first dose of study treatment until 6 months later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

ICON plc

Collaborator

Source ClinicalTrials.gov
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