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JOURNAL ONKOLOGIE – STUDIE

RIBBIT Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line

Rekrutierend

NCT-Nummer:
NCT03462251

Studienbeginn:
Mai 2018

Letztes Update:
27.08.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
iOMEDICO AG

Collaborator:
Novartis Pharmaceuticals

Studienleiter

Thomas Decker, Prof.
Principal Investigator
Gemeinschaftspraxis für Hämatologie und Onkologie

Kontakt

Studienlocations (3 von 27)

Gemeinschaftspraxis für Hämatologie und Onkologie
88212 Ravensburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thomas Decker, Prof.
Phone: +49 751 3661970
E-Mail: thomas.decker@onkonet.eu» Ansprechpartner anzeigen
Uniklinik RWTH Aachen, Gynäkologie und Geburtsmedizin
52074 Aachen
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Elmar Stickeler, Prof. Dr. med.
Phone: +49 0241 808 8400
E-Mail: estickeler@ukaachen.de» Ansprechpartner anzeigen
Darmkrebszentrum Klinikum Mittelbaden Baden-Baden Balg
Balger Straße 50
76532 Baden-Baden
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Antje Hahn, Dr. med.
Phone: +49 7221 9116083
E-Mail: a.hahn@klinikum-mittelbaden.de» Ansprechpartner anzeigen
Gynäkologisches Zentrum Bonn
53111 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christian Martin Kurbacher, PD Dr. med.
Phone: +49 228 22720497
E-Mail: kurbacher@web.de» Ansprechpartner anzeigen
St.-Johannes-Hospital Gynäkologie und Geburtshilfe
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Volker Hagen, Dr. med.
Phone: +49 231 184335611
E-Mail: volker.hagen@joho-dortmund.de» Ansprechpartner anzeigen
BAG / Onkologische Gemeinschaftspraxis
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Lutz Jakobasch, Dr. med.
Phone: +49 351 4472340
E-Mail: jacobasch@onkologie-dresden.net» Ansprechpartner anzeigen
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Anja Welt, Dr. med.
Phone: +49 201 7233100
E-Mail: anja.welt@uk-essen.de» Ansprechpartner anzeigen
Praxis für interdisziplinäre Onkologie & Hämatologie
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mathias Zaiss, Dr. med.
Phone: +49 761 386870
E-Mail: info@onkologie-freiburg.de» Ansprechpartner anzeigen
Überörtliche Berufsausübungsgemeinschaft MVZ Onkologische Kooperation Harz
38642 Goslar
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marc-Oliver Zahn, Dr. med.
Phone: +49 5321 686118
E-Mail: m-o.zahn@onkologie-goslar.de» Ansprechpartner anzeigen
Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
06110 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Timo Behlendorf, Dr. med.
Phone: +49 345 682360
E-Mail: praxis@onkologie-halle.de» Ansprechpartner anzeigen
OncoResearch Lerchenfeld GmbH
22081 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thomas Wolff, Dr. med.
Phone: +49 40 22604652
E-Mail: t.wolff@oncoresearch-lerchenfeld.de» Ansprechpartner anzeigen
Onkologische Schwerpunktpraxis
69115 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stefan Fuxius, Dr. med.
Phone: +49 6221 714990
E-Mail: stefanfuxius@gmx.de» Ansprechpartner anzeigen
Hämato-Onkologisches Zentrum Kassel MVZ GmbH
34119 Kassel
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ulrike Söling, Dr. med.
Phone: +49 561 7393372
E-Mail: info@onkologie-kassel.de» Ansprechpartner anzeigen
Gemeinschaftspraxis für Hämatologie und Onkologie
45468 Mühlheim
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Schröder, PD Dr. med.
Phone: +49 208 76981
E-Mail: jan.schroeder@onkologie-mh.de» Ansprechpartner anzeigen
Hämatologisch-onkologische Gemeinschaftspraxis
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Rüdiger Liersch, PD Dr. med.
Phone: +49 251 620080
E-Mail: liersch@onkologie-muenster.de» Ansprechpartner anzeigen
Praxis und Tagesklinik für Onkologie und Hämatologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Till-Oliver Emde, Dr. med.
Phone: +49 2361 904270
E-Mail: heflik@onkologie-re.de» Ansprechpartner anzeigen
Tumorzentrum und Hausarztpraxis Rötha Leipziger-Land
04571 Rötha
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Runa Stiegler, Dr. med.
Phone: +49 34206 72485
E-Mail: runastiegler@gmx.de» Ansprechpartner anzeigen
Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
78224 Singen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thomas Fietz, Dr. med.
Phone: +49 7731 797660
E-Mail: fietz@onkologie-bodensee.de» Ansprechpartner anzeigen
Onkologische Schwerpunktpraxis
67346 Speyer
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Joachim Behringer, Dr. med.
Phone: +49 6232 604460
E-Mail: j.behringer@onkologie-speyer.de» Ansprechpartner anzeigen
g.SUND Gynäkologie Kompetenzzentrum Stralsund
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Carsten Hielscher, Dr. med.
Phone: +49 3831 3552726
E-Mail: studiensekretariat@gyn-stralsund.de» Ansprechpartner anzeigen
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
78052 Villingen-Schwenningen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Paul Graf La Rosée, Prof. Dr. med.
Phone: +49 7721 934 001
E-Mail: paul.larosee@sbk-vs.de» Ansprechpartner anzeigen
Gemeinschaftspraxis für Hämatologie und Onkologie
26655 Westerstede
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Dietmar Reichert, Dr. med.
Phone: +49 4488 5218880
E-Mail: info@onkologie-westerstede.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a prospective, randomized, open-label, two-arm, multicenter, interventional phase III trial in Germany. The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease.

158 patients will be enrolled and randomized 1:1 (stratified by the presence of lung and / or liver metastases) to receive Arm A: a combination of ribociclib and AI or fulvestrant; OR Arm B: capecitabine + bevacizumab OR paclitaxel +/- bevacizumab

Treatment will be continued until disease progression, intolerable toxicity or death. Progression-free survival (PFS) will be based on tumor assessments by local radiologists/investigator using RECIST v1.1 criteria. Treatment might be continued beyond RECIST-defined progressive disease (PD) in case of negligible or clinically irrelevant disease progression according to the investigator's discretion until clinically relevant disease progression or symptomatic deterioration.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years.

- Any menopausal status. If pre-/perimenopausal, agreement to receive LHRH agonist (goserelin or leuprorelin) / ovarian ablation in case of randomization to arm A

- Locally confirmed diagnosis of metastatic adenocarcinoma of the breast without prior systemic antineoplastic therapy in the palliative setting.

- Hormone receptor (HR)-positive disease, defined as estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive.

- Human epidermal growth factor receptor 2 (HER2)-negative disease (defined as immunohistochemistry (IHC) status HER2 negative/+ or IHC HER2++ with chromosomal in situ hybridization (CISH)/fluorescent in situ hybridization (FISH) negative).

- Presence of visceral metastases (additional non-visceral metastases are allowed).

- Presence of target and / or non-target lesions according to RECIST v1.1

- Patients eligible for palliative treatment with AI / fulvestrant + ribociclib and capecitabine + bevacizumab or paclitaxel + / - bevacizumab according to the respective SmPCs.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

- Adequate organ and bone marrow function within 7 days prior to randomization.

- Standard 12-lead ECG values: QT Interval Corrected by the Fridericia Correction Formula (QTcF) interval at screening < 450 msec; Mean resting heart rate 50-90 bpm (determined from the ECG)

- Signed written informed consent prior to beginning of protocol-specific procedures.

Exclusion Criteria:

- Any prior systemic palliative therapy

- Prior treatment with any cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

- Prior adjuvant or neoadjuvant taxane therapy if last application within 12 months prior to entering the study.

- Patient is concurrently using other anti-cancer therapy.

- Patient has had major surgery within 28 days prior to randomization or has not recovered from major side effects or wound is not fully recovered.

- Patient has received extended-field radiotherapy ≤ 4 weeks or limited-field radiotherapy ≤ 2 weeks prior to randomization.

- Known hypersensitivity to ribociclib, AI, paclitaxel, bevacizumab or any of their excipients, or against peanut, soya, Chinese hamster ovarian cell products or macrogolglycerol ricinoleate-35.

- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality (e.g. history of myocardial infarction within 6 months prior study entry, long QT syndrome, clinically significant cardiac arrhythmias or systolic blood pressure > 140 or < 90 mmHg or diastolic blood pressure > 90 mmHg).

- Patient has history of arterial thrombosis within 12 months prior to entering the study.

- Patient has proteinuria (≥ 2+ on urine dipstick)

- Patient with congenital bleeding diathesis, acquired coagulopathy or under full dose of anticoagulants.

- Patient is currently receiving strong inducers or inhibitors of CYP3A4/5 or medication with narrow therapeutic window that are predominantly metabolized through CYP3A4/5 and cannot be discontinued 7 days prior to start of study treatment.

- Known presence of cerebral metastases unless at least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment and clinically stable central nervous system tumor at the time of screening.

- Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.

- Patient is currently receiving or has received systemic corticosteroids or other chronic immunosuppressive therapy ≤ 2 weeks prior to starting study drug.

- Patients with advanced symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).

- Patient has a known history of HIV infection (testing not mandatory).

- Patient has active untreated or uncontrolled fungal, bacterial or viral infection.

- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, etc.).

- Participation in prior investigational studies within 30 days prior to randomization or within 5-half lives of the investigational product, whichever is longer.

Studien-Rationale

Primary outcome:

1. Efficacy in terms of PFS (Time Frame - Up to approximately 15 months.):
PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 48 months.):
OS is defined as time from randomization to death of any cause.

2. Overall Response Rate (ORR) (Time Frame - Up to approximately 15 months.):
ORR is defined as the proportion of patients with best overall response of complete or partial response according to RECIST 1.1.

3. Clinical Benefit Rate (CBR) (Time Frame - Up to approximately 15 months):
CBR is defined as the proportion of patients with best overall response of complete or partial response or stable disease lasting 24 weeks or more according to RECIST 1.1.

4. Time To Response (TTR) (Time Frame - Up to approximately 15 months.):
TTR is defined as time from randomization to first occurrence of any response (complete or partial) according to RECIST 1.1.

5. Number of participants with Adverse Events (Time Frame - Until 30 days after end of treatment, up to approximately 16 months.):
Type, frequency and severity (according to CTCAE v4.03) of adverse events

6. Time to deterioration of ECOG performance status (Time Frame - Until 30 days after end of treatment, up to approximately 16 months):
Time to deterioration of ECOG performance status by at least one point from baseline.

7. Tolerability of treatment (Time Frame - Until 30 days after end of treatment, up to approximately 16 months.):
By-patient listings of safety laboratory (hemoglobin, platelets, white blood cells with differentials, international normalized ratio , serum creatinine, bilirubin, Alanine-Aminotransferase (ALT) and Aspartate-Aminotransferase (AST)).

8. corrected QT interval (QTc) time (Time Frame - Until 30 days after end of treatment, up to approximately 16 months.):
By-patient listings of cardiac monitoring.

9. Health-related quality of life (QoL) (Time Frame - Up to 36 months.):
Health-related QoL will be assessed with the EORTC Quality of life questionnaire (QLQ) QLQ-C30.

10. Side effects of treatment (Time Frame - Up to 36 months.):
One question on treatment burden

11. Time spent on treatment (Time Frame - Up to 36 months):
Burden by treatment will be assessed with 4 questions on time spent on treatment

Studien-Arme

  • Experimental: Arm A
    Combination of ribociclib and aromatase inhibitor or fulvestrant
  • Active Comparator: Arm B
    Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab

Geprüfte Regime

  • Ribociclib and aromatase inhibitor or fulvestrant:
    Combination of ribociclib and aromatase inhibitor or fulvestrant
  • Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab:
    Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab

Quelle: ClinicalTrials.gov


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