Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Abemacare
Previous Study | Return to List | Next Study

Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients With Symp-tomatic Visceral Metastases or High Tumor Burden (Abemacare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681768
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment
Breast Cancer/ Metastatic Breast Cancer Drug: Abemaciclib

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients With Symp-tomatic Visceral Metastases or High Tumor Burden
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib


Intervention Details:
  • Drug: Abemaciclib
    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)


Primary Outcome Measures :
  1. objective response rate (ORR) while being on study treatment using RECIST V1.1. [ Time Frame: Maximum time frame will be 48 months ]
    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.


Secondary Outcome Measures :
  1. ORR at first, second and third time point of tumor evaluation [ Time Frame: Maximum time frame will be 48 months ]
    ORR at first, second and third time point of tumor evaluation (according to clinical routine every 8 weeks) defined as the proportion of patients with having partial or complete response at first, second and third time point of tumor evaluation after initiation of study treatment using RECIST V1.1.

  2. Disease control rate (DCR= CR+PR+SD) at first, second and third time point of tumor evaluation [ Time Frame: Maximum time frame will be 48 months ]
    Disease control rate (DCR= CR+PR+SD) at first, second and third time point of tumor evaluation after initiation of study treatment (according to clinical routine every 8 weeks)

  3. Duration of response (DoR) [ Time Frame: Maximum time frame will be 48 months ]
    Duration of response (DoR), defined as the time from first documentation of OR to first documentation of PD according to RECISTV1.1 or death of any cause

  4. Clinical response rate (CRR) at 4, 8, 16 and 24 weeks after initiation of study treatment [ Time Frame: zp to 24 weeks ]
    Clinical response rate (CRR) at 4, 8, 16 and 24 weeks after initiation of study treatment defined as the proportion of patients assessed by the investigator as having at least one sign or symptom of clinical response.

  5. Clinical benefit rate (CBR) [ Time Frame: Maximum time frame will be 48 months ]
    Clinical benefit rate (CBR), defined as the percentage of patients with CR, PR or SD for at least 24 weeks [Time frame: initiation of study treatment to PD or death of any cause

  6. Time to initial response (TTR) [ Time Frame: Maximum time frame will be 48 months ]
    Time to initial response (TTR), defined as the time from initiation of study treatment to first documentation of objective response

  7. Progression-free survival (PFS) [ Time Frame: Maximum time frame will be 48 months ]
    Progression-free survival (PFS), defined as the time from initiation of study treatment until objective tumor progression or death, whichever occurs first

  8. Time to treatment failure (TTF) [ Time Frame: Maximum time frame will be 48 months ]
    Time to treatment failure (TTF), defined as the time from initiation of study treatment to discon-tinuation of treatment for any reason, including disease progression, treatment toxicity, and death

  9. Change in tumor size [ Time Frame: Maximum time frame will be 48 months ]
    Change in tumor size, defined as change of largest tumor-diameter on baseline tumor evaluation during the course of study treatment

  10. Frequency of AE/SAE during study [ Time Frame: Maximum time frame will be 48 months ]
    occurenec of AE/SAE during study

  11. Patient reported outcomes (PRO) [ Time Frame: Maximum time frame will be 48 months ]
    Patient reported outcomes (PRO): change from baseline to end of study in symptom burden and quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Minimum score =0 Maximum score = 100. Higher score would mean a better outcome


Biospecimen Retention:   Samples With DNA
Correlation analyses between circulating tumor DNA (ctDNA), protein tumormarkers and ORR/CRR


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer/ metastatic breast cancer
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. 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
  3. Signed informed consent
  4. Life expectancy greater or equal to 12 weeks
  5. Histologically proven diagnosed estrogen receptor positive, HER2 negative metastatic breast cancer not amenable to curative treatment
  6. Radiographic evidence of measurable or evaluable visceral disease
  7. Visceral involvement must fulfil one of the following criteria:

    1. 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)
    2. 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 Criteria:

  1. Contraindications for treatment with Abemaciclib, aromatase inhibitor or Fulvestrant according to current SmPC
  2. Prior first line therapy (endocrine or chemotherapy) for metastatic breast cancer
  3. Prior treatment with any CDK4/6 inhibitor (or participation in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
  4. Bone-only disease
  5. Participation in clinical trials using an IMP within the last four weeks prior to inclusion (ICF)
  6. 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
  7. Patients who are pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681768


Contacts
Layout table for location contacts
Contact: Johannes Ettl, MD :+49-89-4140-2433 johannes.ettl@tum.de

Locations
Layout table for location information
Germany
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde Recruiting
Munich, Germany, 81675
Contact: Johannes Ettl, MD       johannes.ettl@tum.de   
Sponsors and Collaborators
Technische Universität München
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Chair: Johannes Ettl, MD Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
Layout table for additonal information
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT04681768    
Other Study ID Numbers: I3Y-NS-O003
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: it is not planed to share IPDs

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases