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

Primary Purpose

Breast Cancer, Breast Neoplasms, Breast Neoplasm Female

Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ribociclib
Sponsored by
Institut fuer Frauengesundheit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Gynecology and Obstetrics, Erlangen University HospitalRecruiting
  • Department of Gynecology and Obstetrics, University Medicine MainzRecruiting
  • Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbHRecruiting
  • Klinikum St Marien AmbergRecruiting
  • Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum AschaffenburgRecruiting
  • Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
  • University Hospital AugsburgRecruiting
  • Frauenklinik des Klinikums Bamberg
  • MediOnko GbR
  • HELIOS Klinikum Berlin-Buch
  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
  • Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
  • Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe
  • Kliniken Der Stadt Köln gGmbHRecruiting
  • Carl-Thiem-Klinikum CottbusRecruiting
  • Staedtisches Klinikum Dessau, Gynecology and ObstetricsRecruiting
  • Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden
  • Universitaetsklinikum Duesseldorf AöRRecruiting
  • Universitaetsklinikum Essen AöR, Gynecology and Obstetrics
  • Klinikum Esslingen GmbH
  • Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics
  • Universitäts-Frauenklinik Frankfurt
  • Universitäts-Frauenklinik Freiburg
  • Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und BramscheRecruiting
  • Universitäts-Frauenklinik Hamburg-Eppendorf
  • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und GeburtshilfeRecruiting
  • Frauenklinik, SLK-Kliniken Heilbronn GmbHRecruiting
  • Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and ObstetricsRecruiting
  • University Medical Centre Schleswig-Holstein, Gynecology and ObstetricsRecruiting
  • ZAGO-Zentrum für ambulante gynäkologische OnkologieRecruiting
  • Klinikum KulmbachRecruiting
  • VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf
  • Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms
  • Universitäts-Frauenklinik Leipzig
  • Hämatologie Onkologie Gemeinschaftspraxis PasingRecruiting
  • Ev. Krankenhaus Bethesda Mönchengladbach
  • MVZ Nordhausen gGmbHRecruiting
  • Klinikum Nürnberg
  • Frauenklinik, Medius Klinik NürtingenRecruiting
  • Gemeinschaftspraxis für Hämatologie und Onkologie GbRRecruiting
  • Frauenklinik, Diakoniekrankenhaus RotenburgRecruiting
  • Leopoldina Krankenhaus der Stadt Schweinfurt gGmbHRecruiting
  • Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm DiagnostikRecruiting
  • Onkologische Schwerpunktpraxis SpeyerRecruiting
  • Klinikum Stuttgart
  • Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie
  • Universitaetsklinikum TuebingenRecruiting
  • Universitäts-Frauenklinik Ulm
  • MVZ Nordoberpfalz
  • Medizinische Studiengesellschaft Nord-West GmbHRecruiting
  • Rems-Murr Kliniken WinnendenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ribociclib

Arm Description

Outcomes

Primary Outcome Measures

12-month PFS rate
The rate for progression-free survival at month 12 will be calculated.
12-month OS rate
The rate for overall survival at month 12 will be calculated.

Secondary Outcome Measures

24-month PFS rate
The rate for progression-free survival at month 24 will be calculated.
24-month OS rate
The rate for overall survival at month 24 will be calculated.
36-month PFS rate
The rate for progression-free survival at month 36 will be calculated.
36-month OS rate
The rate for overall survival at month 36 will be calculated.
Median progression-free survival
Median progression-free survival will be estimated if achieved at the end of study
Median overall survival
Median overall survival will be estimated if achieved at the end of study
Health related quality of life (FACT-G)
Health related quality of life as assessed by FACT-G questionnaire (Functional Assessment of Cancer Therapy - General) Min 0, Max 108, The higher the score, the better the QoL.
Health related quality of life (FACT-B)
Health related quality of life as assessed by FACT-B questionnaire (Functional Assessment of Cancer Therapy - Breast Cancer) Min 0, Max 148, The higher the score, the better the QoL.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The safety endpoints for the study will include rate of adverse events (AE), serious adverse events (SAEs) and fatal SAEs, causality and outcome of AE/SAEs, rate of treatment discontinuations and reasons, Changes in vital signs, laboratory values etc. Grading of AE/SAEs will be based on NCI CTCAE v5.0.

Full Information

First Posted
June 28, 2022
Last Updated
April 14, 2023
Sponsor
Institut fuer Frauengesundheit
Collaborators
AGO Breast Study Group e.V., Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05452213
Brief Title
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Acronym
CAPTOR-BC
Official Title
CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fuer Frauengesundheit
Collaborators
AGO Breast Study Group e.V., Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This is a prospective, multicenter, phase IV, one-arm, open-label clinical trial investigating patients treated with ribociclib and standard of care endocrine therapy for hormone receptor positive (HR+) / human epidermal growth factor receptor negative (HER2-) advanced breast cancer in the first therapy line. Patients eligible for this trial will receive on-label ribociclib according to Summary of Product Characteristics (SmPC) and as well as the specified inclusion/exclusion criteria. The survival rates for progression-free survival (PFS) and overall survival (OS) at month 12 are the co-primary objectives. Quality of life and toxicity are secondary objectives. Additionally, there is a comprehensive biomarker discovery and validation program included into the study. A total of 1000 patients are planned to be enrolled into this trial in 75 trial sites in Germany. Biomarkers will be evaluated before, during and after treatment or at progression. A comprehensive biospecimens sampling will be done to enable translational research projects and evaluation of potential biomarkers within circulation tumor desoxyribonucleic acid (ctDNA), circulating tumor ribonucleic acid (ctRNA), formaldehyde-fixed paraffin-embedded tissue (FFPE) tissue, Serum, Plasma and circulating immune cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Neoplasm Female, Breast Cancer Female, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Advanced Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
One-arm, open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribociclib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ribociclib
Intervention Description
All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.
Primary Outcome Measure Information:
Title
12-month PFS rate
Description
The rate for progression-free survival at month 12 will be calculated.
Time Frame
12 months
Title
12-month OS rate
Description
The rate for overall survival at month 12 will be calculated.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
24-month PFS rate
Description
The rate for progression-free survival at month 24 will be calculated.
Time Frame
24 months
Title
24-month OS rate
Description
The rate for overall survival at month 24 will be calculated.
Time Frame
24 months
Title
36-month PFS rate
Description
The rate for progression-free survival at month 36 will be calculated.
Time Frame
36 months
Title
36-month OS rate
Description
The rate for overall survival at month 36 will be calculated.
Time Frame
36 months
Title
Median progression-free survival
Description
Median progression-free survival will be estimated if achieved at the end of study
Time Frame
From date of enrollment until first documented progression or date of death from any cause or regular end of study (up to 24 months) whichever is first.
Title
Median overall survival
Description
Median overall survival will be estimated if achieved at the end of study
Time Frame
From date of enrollment until date of death from any cause or regular end of study (up to 24 months) whichever is first.
Title
Health related quality of life (FACT-G)
Description
Health related quality of life as assessed by FACT-G questionnaire (Functional Assessment of Cancer Therapy - General) Min 0, Max 108, The higher the score, the better the QoL.
Time Frame
Collected before start of trial treatment, at 3 months and every 6 months afterwards until end of study up to 24 months
Title
Health related quality of life (FACT-B)
Description
Health related quality of life as assessed by FACT-B questionnaire (Functional Assessment of Cancer Therapy - Breast Cancer) Min 0, Max 148, The higher the score, the better the QoL.
Time Frame
Collected before start of trial treatment, at 3 months and every 6 months afterwards until end of study up to 24 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Description
The safety endpoints for the study will include rate of adverse events (AE), serious adverse events (SAEs) and fatal SAEs, causality and outcome of AE/SAEs, rate of treatment discontinuations and reasons, Changes in vital signs, laboratory values etc. Grading of AE/SAEs will be based on NCI CTCAE v5.0.
Time Frame
All adverse events will be recorded from signing informed consent through 30 days following cessation of treatment or until the last study visit
Other Pre-specified Outcome Measures:
Title
Correlation of genome wide genetic biomarkers with progression-free survival
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide genetic biomarkers with overall survival
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide genetic biomarkers with quality of life
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide genetic biomarkers with ribociclib side effects
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide gene expression biomarkers with progression-free survival
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide gene expression biomarkers with overall survival
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide gene expression biomarkers with quality of life
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide gene expression biomarkers with ribociclib side effects
Description
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with progression-free survival
Description
Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline and at the time of tumor progression
Title
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with overall survival
Description
Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline and at the time of tumor progression
Title
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with quality of life
Description
Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline and at the time of tumor progression
Title
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with ribociclib side effects
Description
Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline and at the time of tumor progression
Title
Correlation of genome wide tumor mutational patterns assessed from ctDNA biomarkers with progression-free survival
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide tumor mutational patterns assessed from ctDNA biomarkers with overall survival
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide tumor mutational patterns assessed from ctDNA biomarkers with quality of life
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of genome wide tumor mutational patterns assessed from ctDNA biomarkers with ribociclib side effects
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with progression-free survival
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with overall survival
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with quality of life
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.
Title
Correlation of changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with ribociclib side effects
Description
Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.
Time Frame
Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 (CDK4/6) inhibitors is allowed in the adjuvant 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 (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 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 after the last dose of trial treatment. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. Exclusion Criteria: 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 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). 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). Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CAPTOR Study Manager
Phone
09131 9278638
Email
captor@ifg-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Fasching, MD, Prof.
Organizational Affiliation
Department of Gynecology and Obstetrics, Erlangen University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanja Fehm, MD, Prof.
Organizational Affiliation
Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Schneeweiss, MD, Prof.
Organizational Affiliation
National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynecology and Obstetrics, Erlangen University Hospital
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter A Fasching, MD, Prof.
Phone
+49 9131 8543470
Email
peter.fasching@uk-erlangen.de
Facility Name
Department of Gynecology and Obstetrics, University Medicine Mainz
City
Mainz
State/Province
Hesse
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Schmidt, MD, Prof.
Phone
+49 6131 176884
Email
marcus.schmidt@unimedizin-mainz.de
Facility Name
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
City
Bottrop
State/Province
North Rhine-Westphalia
ZIP/Postal Code
46236
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Christian Kolberg, MD
Phone
+49 2041 1061601
Email
hans-christian.kolberg@mhb-bottrop.de
Facility Name
Klinikum St Marien Amberg
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja H Haunzenberger, MD
Phone
+499621381381
Email
haunzenberger.tanja@klinikum-amberg.de
Facility Name
Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manfred Welslau, MD
Email
manfred.welslau@klinikum-ab-alz.de
Facility Name
Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Jordan, MD
Email
Frank.Jordan@uk-augsburg.de
Facility Name
University Hospital Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Ditsch, MD, Prof.
Phone
+498214002208
Email
nina.ditsch@uk-augsburg.de
Facility Name
Frauenklinik des Klinikums Bamberg
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Wrobel, MD
Email
studienzentrale@sozialstiftung-bamberg.de
Facility Name
MediOnko GbR
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülten Oskay-Özcelik, MD
Email
studienoskay@medionko.de
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Untch, MD
Email
michael.untch@helios-gesundheit.de
Facility Name
Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
City
Bonn
ZIP/Postal Code
53129
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Esser, MD
Email
messer@zaho-rheinland.de
Facility Name
Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Aydogdu, MD
Email
studien_kbm_gyn@gesundheitnord.de
Facility Name
Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Krabisch, MD
Email
p.krabisch@skc.de
Facility Name
Kliniken Der Stadt Köln gGmbH
City
Cologne
ZIP/Postal Code
51067
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam EM Vincent
Phone
+4922189076700
Email
vincentm@kliniken-koeln.de
Facility Name
Carl-Thiem-Klinikum Cottbus
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikola Bangemann, MD
Email
N.Bangemann@ctk.de
Facility Name
Staedtisches Klinikum Dessau, Gynecology and Obstetrics
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Voß, MD
Phone
+493405014310
Email
hermann.voss@klinikum-dessau.de
Facility Name
Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Wimberger, MD
Email
pauline.wimberger@uniklinikum-dresden.de
Facility Name
Universitaetsklinikum Duesseldorf AöR
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Fehm, MD, Prof.
Phone
+492118117501
Email
direktion.frauenklinik@med.uni-duesseldorf.de
Facility Name
Universitaetsklinikum Essen AöR, Gynecology and Obstetrics
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Hoffmann, MD
Phone
+492017232575
Email
oliver.hoffmann@uk-essen.de
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Hein, MD
Email
a.hein.cto@klinikum-esslingen.de
Facility Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics
City
Frankfurt Am Main
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc AM Thill, MD, Prof.
Phone
+496995332228
Email
marc.thill@agaplesion.de
Facility Name
Universitäts-Frauenklinik Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Solbach, MD
Email
Christine.Solbach@kgu.de
Facility Name
Universitäts-Frauenklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingolf Juhasz-Böss, MD
Email
ingolf.juhasz-boess@uniklinik-freiburg.de
Facility Name
Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Lüdtke-Heckenkamp, MD
Email
kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
Facility Name
Universitäts-Frauenklinik Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volkmar Müller, MD
Email
v.mueller@uke.de
Facility Name
Mammazentrum Hamburg am Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schem, MD
Email
schem@mammazentrum-hamburg.de
Facility Name
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schneeweiss, MD
Email
Andreas.Schneeweiss@med.uni-heidelberg.de
Facility Name
Frauenklinik, SLK-Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaus De Gregorio, MD
Email
nikolaus.degregorio@slk-kliniken.de
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gariele Kaltenecker, MD
Phone
+4972197462406
Email
gabriele.kaltenecker@klinikum-karlsruhe.de
Facility Name
University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion van Mackelenbergh, MD
Phone
+4943150021410
Email
marion.vanmackelenbergh@uksh.de
Facility Name
ZAGO-Zentrum für ambulante gynäkologische Onkologie
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunther M Rogmans, MD
Phone
+492151322969
Email
rogmans.gunther@gmail.com
Facility Name
Klinikum Kulmbach
City
Kulmbach
ZIP/Postal Code
95326
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benno Lex, MD
Phone
+499221981901
Email
benno.lex@klinikum-kulmbach.de
Facility Name
VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Vehling-Kaiser, MD
Email
dr.vk@vehling-kaiser.de
Facility Name
Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms
City
Leer
ZIP/Postal Code
26789
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lothar Müller, MD
Email
lothar.mueller@onkologie-ue.de
Facility Name
Universitäts-Frauenklinik Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahriye Aktas, MD
Email
Bahriye.Aktas@medizin.uni-leipzig.de
Facility Name
Hämatologie Onkologie Gemeinschaftspraxis Pasing
City
Munich
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Zingerle, MD
Email
zingerle@onkologie-pasing.de
Facility Name
Ev. Krankenhaus Bethesda Mönchengladbach
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Scheffen, MD
Email
iris.scheffen@wsg-online.com
Facility Name
MVZ Nordhausen gGmbH
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Grafe, MD
Email
andrea.grafe@shk-ndh.de
Facility Name
Klinikum Nürnberg
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Zeder-Göß, MD
Phone
+499113983843
Email
christine.zeder-goess@klinikum-nuernberg.de
Facility Name
Frauenklinik, Medius Klinik Nürtingen
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elke Faust, MD
Email
e.faust@medius-kliniken.de
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Decker, MD
Email
thomas.decker@onkonet.eu
Facility Name
Frauenklinik, Diakoniekrankenhaus Rotenburg
City
Rotenburg
ZIP/Postal Code
27356
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Hesse, MD
Email
hesse@diako-online.de
Facility Name
Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Weigel, MD
Email
mweigel@leopoldina.de
Facility Name
Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik
City
Singen
ZIP/Postal Code
78224
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Fietz, MD
Email
studie@onkologie-bodensee.de
Facility Name
Onkologische Schwerpunktpraxis Speyer
City
Speyer
ZIP/Postal Code
61346
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor Bolz, MD
Email
g.bolz@onkologie-speyer.de
Facility Name
Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Karck, MD
Email
u.karck@klinikum-stuttgart.de
Facility Name
Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie
City
Troisdorf
ZIP/Postal Code
53840
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernst Rodermann, MD
Email
rodermann@onkologie-rheinsieg.de
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva-Maria Grischke, MD, Prof.
Phone
+4970712982211
Email
eva-maria.grischke@med.uni-tuebingen.de
Facility Name
Universitäts-Frauenklinik Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte Rack, MD
Email
Studienzentrale.UFK@uniklinik-ulm.de
Facility Name
MVZ Nordoberpfalz
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Funck, MD
Email
robert.funck@mvz-weiden.de
Facility Name
Medizinische Studiengesellschaft Nord-West GmbH
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Janssen, MD
Facility Name
Rems-Murr Kliniken Winnenden
City
Winnenden
ZIP/Postal Code
71364
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Joachim Strittmatter, MD
Email
ans-joachim.strittmatter@rems-murr-kliniken.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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