A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

ribociclib

Clinical Study ID

NCT06075758
CLEE011AIC01
  • Ages 18-100
  • All Genders

Study Summary

This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combinationwith hormonal therapy.

  2. Advanced /metastatic breast cancer

  3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.

  4. HER2-negative breast cancer.

  5. Patients who received or currently receiving Ribociclib in combination with hormonaltherapy in the first or second-line settings as per the routine practice.

  6. For the ambispective part, patients should have initiated the Ribociclib, incombination with hormonal therapy, line of treatment at least 12 months before thepatient's recruitment date and still continuingcontinuing the drug at the baselinevisit.

  7. For retrospective patients only, the patients should have been on Ribocilib, incombination with hormonal therapy, for at least 18 months and stopped Ribociclibbefore the SIV date.enrollment

  8. For ambispective part, patients agree to sign informed consent before theirenrollment.

Exclusion

Exclusion Criteria:

  1. Ribociclib-based treatment regimen beyond the second line.

  2. Patients are currently participating in any other clinical trials.

  3. Patient with a known hypersensitivity to any of the excipients of Ribociclib.

  4. Patients who previously received any other CDK4/6 inhibitor .

  5. For ambispective patients, patients who refuse to sign the informed consent

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: ribociclib
Phase:
Study Start date:
March 07, 2024
Estimated Completion Date:
June 30, 2025

Study Description

The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment.

Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.

Data will be collected from patient electronic medical records in the sites chosen for patients who received Ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions.

A total of 550 patients is planned for this study. The planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.

Connect with a study center

  • Novartis Investigative Site

    Amman, 11941
    Jordan

    Active - Recruiting

  • Novartis Investigative Site

    Muscat, 1331
    Oman

    Active - Recruiting

  • Novartis Investigative Site

    Riyadh, 11211
    Saudi Arabia

    Active - Recruiting

  • Novartis Investigative Site

    Al Ain Abu Dhabi,
    United Arab Emirates

    Active - Recruiting

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