What is ribociclib studying for advanced breast cancer?

Ribociclib is being studied in combination with standard endocrine therapy for women with advanced hormone receptor-positive, HER2-negative breast cancer. Researchers aim to understand how ribociclib works over time, its effectiveness, and patterns of resistance. The study also includes biomarker research to learn more about treatment response and survival outcomes.

Who may be eligible for this advanced breast cancer clinical trial?

Women aged 18 years or older with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer receiving first-line treatment with ribociclib and endocrine therapy may be eligible. Participants must have adequate organ function and not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced breast cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 4

Age: 18Years +

FEMALE

ID05452213

CAPTOR-BC Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

Led by Institut fuer Frauengesundheit · Updated on 2023-04-18

1000

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

CONDITIONS

Brief Title

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Indication for treatment with ribociclib combined with endocrine therapy for locally advanced or first-line metastatic breast cancer according to SmPC
Signed informed consent before any trial-specific procedures
Female aged 18 years or older at consent
Locally advanced or metastatic breast cancer not suitable for curative treatment
HER2-negative breast cancer confirmed by local lab tests including immunohistochemistry and in situ hybridization as needed
Histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive breast cancer by core biopsy
Corrected QT interval (QTcF) less than 450 ms
Adequate organ function for ribociclib treatment as per local labs
For women of childbearing potential, negative pregnancy test within 72 hours before study entry and agreement to use effective contraception during and 21 days after treatment
Willingness and ability to comply with study visits, treatments, lab tests, and procedures

You will not qualify if you...

Participation in another trial with an investigational drug or device within 14 days or 5 half-lives before study entry
Not treated for advanced HR+, HER2- breast cancer as first-line therapy
Ineligibility for ribociclib treatment as per SmPC or investigator decision
Pregnancy or lactation
Existing or high risk of corrected QT interval prolongation, including long QT syndrome, serious cardiac disease, or electrolyte imbalances
Known allergy to ribociclib, soya, peanut, or its excipients
Active systemic infections requiring systemic treatment or known active viral infections like HIV or hepatitis B/C
Serious medical conditions that could interfere with study participation, such as severe renal impairment, lung disease, oxygen-dependent breathing difficulties, prior major stomach or bowel surgery, inflammatory bowel diseases, or chronic diarrhea
Refusal to provide biospecimens such as blood, stool, or tissue samples

Research Team

CAPTOR Study Manager

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