Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients

Korábbi kezelés

• Contraindications for treatment with Abemaciclib, aromatase inhibitor or Fulvestrant according to current SmPC
• Prior first line therapy (endocrine or chemotherapy) for metastatic breast cancer
• Prior treatment with any CDK4/6 inhibitor (or participation in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
• Participation in clinical trials using an IMP within the last four weeks prior to inclusion (ICF)
• Treatment with a drug that has not received regulatory approval for any indication within 28 days of initiation of study treatment for a non-myelosuppressive or myelosuppressive agent, respectively

Más betegség

• Bone-only disease

Egyéb

• Patients who are pregnant or breast-feeding

• Age ≥18 years
• Female patients who will start endocrine therapy (aromatase inhibitor or Fulvestrant) in combination with Abemaciclib as first line treatment for metastatic breast cancer within clinical routine
• Signed informed consent
• Life expectancy greater or equal to 12 weeks
• Histologically proven diagnosed estrogen receptor positive, HER2 negative metastatic breast cancer not amenable to curative treatment
• Radiographic evidence of measurable or evaluable visceral disease
• Visceral involvement must fulfil one of the following criteria:
  • Presence of any clinical sign or symptom from visceral disease (at least one of the following: pleural effusion, ascites, abdominal pain from liver or peritoneal metastases, dyspnea from pleural effusion or lymphangiosis of the lung, elevated liver enzymes (> 2x ULN), elevated bil-irubin)
  • Signs of high tumor burden (at least one of the following: LDH >399 U/l with K in normal range, abnormal (> 2x ULN) CEA or CA15-3 level, radiographic signs of lymphangiosis of the lung, cytologically proven bone marrow infiltration)