Status:
COMPLETED
Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Breast Cancer/ Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Breast cancer is one of the most common cancers in women. 20-30 % of all breast cancer patients are faced with advanced disease, comprising both locally advanced breast cancer (LABC) and metastatic br...
Detailed Description
Against the above discussed background there is a clear rationale to further collect real world data confirming that the use of endocrine based therapy in metastatic breast cancer is beneficial for th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
- Bone-only disease
- 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
- Patients who are pregnant or breast-feeding
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04681768
Start Date
December 22 2020
End Date
April 1 2025
Last Update
September 26 2025
Active Locations (1)
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1
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
Munich, Germany, 81675