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Tests treatment safety and results for Breast Cancer
Official title Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
ClinicalTrials.gov ID: NCT05452213
What this study is testing
What is Ribociclib?
Ribociclib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting...
- Written informed consent prior to beginning of trial specific procedures
- Subject must be female and aged ≥ 18 years on the day of signing informed consent
- Locally advanced or metastatic breast cancer not amenable to curative treatment
- Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry...
You likely can't join if
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective...
- Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
- Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
- Patients who are pregnant or lactating.
- Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes
- patients with long QT syndrome
See the full eligibility criteria
- 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...
- Written informed consent prior to beginning of trial specific procedures
- Subject must be female and aged ≥ 18 years on the day of signing informed consent
- Locally advanced or metastatic breast cancer not amenable to curative treatment
- 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...
- Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.
- corrected QT (QTcF) interval \< 450 ms
- Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
- 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...
- Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- 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
- Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
- Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
- Patients who are pregnant or lactating.
- 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
- Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.
- 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...
- 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...
- Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Bavaria, Germany
- Mainz, Hesse, Germany
- Bottrop, North Rhine-Westphalia, Germany
- Amberg, Germany
- Aschaffenburg, Germany
- Augsburg, Germany
- Bamberg, Germany
- Berlin, Germany
- Bonn, Germany
- Bremen, Germany
- Chemnitz, Germany
- Cologne, Germany
- Cottbus, Germany
- Dessau, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Esslingen am Neckar, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Bavaria, Germany; Mainz, Hesse, Germany; Bottrop, North Rhine-Westphalia, Germany; Amberg, Germany; Aschaffenburg, Germany; Augsburg, Germany and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.