Select Your Region
Americas
Europa
Afrika
Weltweit
Teilnehmende, medizinische Einrichtungen finden und deren aktuellen Studienstatus anzeigen
Teilnehmende, medizinische Einrichtungen finden
-
Startseite
-
Suche nach klinischen Studien
- SANDPIPER
Eine Studie zu Taselisib + Fulvestrant im Vergleich zu Placebo + Fulvestrant bei Patientinnen mit fortgeschrittenem oder metastasierendem Brustkrebs, bei denen es während oder nach einer Therapie mit Aromatasehemmern zu einem Wiederauftreten oder einer Progression der Erkrankung kommt
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER)
Krebs Brustkrebs
Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Studien-ID
NCT02340221, GO29058, 2014-003185-25
Condition
Breast Cancer
Official Title
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Einschlusskriterien
Weiblich
≥18 Years
No
Inclusion Criteria
- Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
- Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
- Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
- Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1
- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing
- A valid cobas PIK3CA mutation result by central testing is required
- Adequate hematologic and end-organ function within 28 days prior to treatment initiation
Exclusion Criteria
- Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)
- Prior treatment with fulvestrant
- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor
- Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
- Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
- All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator
- Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
- Concurrent hormone replacement therapy
- Known untreated or active central nervous system (CNS) metastases
- Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
- History of inflammatory bowel disease or active bowel inflammation
- Clinically significant cardiac or pulmonary dysfunction
- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus
Diese Seite fasst Informationen von öffentlichen Studienregister-Websites wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. zusammen. Weitere Informationen zu dieser Studie finden Sie auf der Registerkarte „Für medizinische Fachkräfte" oder auf einer der Studienregister-Websites.
Die Informationen stammen direkt von Websites öffentlicher Register wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. und wurden nicht modifiziert.
Results Disclaimer
Entdecken Sie ähnliche Studien
Studienergebnisse
LPS GO29058 SANDPIPER Interim Results February 2021 German
(PDF, 0.3 MB)
Entdecken Sie ähnliche Studien
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
Teilen Sie Informationen über diese klinische Studie
Link to Pagedurch eine der folgenden Optionen
In die Zwischenablage kopiert