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Analyzing the effects of ribociclib in advanced breast cancer patients

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

Phase 4 Interventional Institut fuer Frauengesundheit · NCT05452213

This study is testing if adding ribociclib to standard hormone therapy can help women with advanced breast cancer live longer and feel better.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexFemale
SponsorInstitut fuer Frauengesundheit Academic / other
Locations52 sites (Erlangen, Bavaria and 51 other locations)
Trial IDNCT05452213 on ClinicalTrials.gov

What this trial studies

This phase IV clinical trial investigates the efficacy and resistance patterns of ribociclib combined with standard endocrine therapy in women with advanced HR+/HER2- breast cancer. It is a single-arm, open-label study that aims to enroll 1000 patients across 75 sites in Germany. The primary objectives include assessing progression-free survival and overall survival at 12 months, while secondary objectives focus on quality of life and toxicity. Additionally, the study incorporates a comprehensive biomarker discovery program to evaluate various biological samples throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with locally advanced or metastatic HER2-negative breast cancer who are eligible for ribociclib treatment.

Not a fit: Patients with HER2-positive breast cancer or those not eligible for ribociclib treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and personalized therapy for patients with advanced breast cancer.

How similar studies have performed: Other studies have shown promising results with ribociclib in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4/6 (CDK4/6) inhibitors is allowed in the adjuvant setting)
2. Written informed consent prior to beginning of trial specific procedures
3. Subject must be female and aged ≥ 18 years on the day of signing informed consent
4. Locally advanced or metastatic breast cancer not amenable to curative treatment
5. Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory
6. Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.
7. corrected QT (QTcF) interval \< 450 ms
8. Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
9. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment.
10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

Exclusion Criteria:

1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
2. Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
3. Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
4. Patients who are pregnant or lactating.
5. Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes

   * patients with long QT syndrome
   * uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia
   * electrolyte abnormalities
6. Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.
7. Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive).
8. Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea).
9. Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)

Where this trial is running

Erlangen, Bavaria and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerBreast NeoplasmsBreast Neoplasm FemaleBreast Cancer FemaleHER2-negative Breast CancerHormone Receptor-positive Breast CancerAdvanced Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.