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

NCT04681768 | Completed

• 1 other identifier: I3Y-NS-O003
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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 breast cancer (MBC). 80% of MBC cases are diagnosed as hormone receptor (HR) positive disease. The main systemic treatment options for these women include endocrine therapy (ET). The need of over-coming de novo or acquired resistance to ET in metastatic breast cancer has led to the integration of CDK4/6 inhibitors into combined ET of MBC. Abemaciclib represents a selective and potent small molecule inhibitor of CDK4/6 which has been granted approval by the European Medical Association (EMA). In two phase III trials Abemaciclib has been shown to double treatment efficacy in terms of PFS prolongation, to improve ORR and to prolong overall survival. At the same time, it has been shown that side effects of the drug are well manageable and QoL of patients under Abemaciclib is maintained.

Conditions

Breast Cancer/ Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR) while being on study treatment using RECIST V1.1.

  Aim of this observational study is to collect efficacy data within clinical routine on Abemaciclib in combi-nation with endocrine therapy in estrogen receptor (ER) positive, HER2 negative metastatic breast cancer patients with symptomatic visceral disease or disease with high tumor burden.

  Maximum time frame will be 48 months

Secondary Outcomes (11)

• ORR at first, second and third time point of tumor evaluation

  Maximum time frame will be 48 months

• Disease control rate (DCR= CR+PR+SD) at first, second and third time point of tumor evaluation

  Maximum time frame will be 48 months

• Duration of response (DoR)

  Maximum time frame will be 48 months

• Clinical response rate (CRR) at 4, 8, 16 and 24 weeks after initiation of study treatment

  zp to 24 weeks

• Clinical benefit rate (CBR)

  Maximum time frame will be 48 months

Interventions

Abemaciclib DRUG

Abemaciclib tablets 150 mg, 100 mg, 50 mg as clinical routine: 150 mg twice daily per os, in-label administration in combination with endocrine therapy (aromatase inhibitor or Fulvestrant)

Also known as: Verzenios®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer/ metastatic breast cancer

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde

Munich, 81675, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Correlation analyses between circulating tumor DNA (ctDNA), protein tumormarkers and ORR/CRR

MeSH Terms

Interventions

abemaciclib

Study Officials

• Johannes Ettl, MD

  Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: December 22, 2020
• Primary Completion: January 20, 2025
• Study Completion: April 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)