Using Abemaciclib with Endocrine Therapy for Metastatic Breast Cancer
Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients With Symp-tomatic Visceral Metastases or High Tumor Burden
This study is testing if combining Abemaciclib with hormone therapy can help women with advanced breast cancer feel better as their first treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Technical University of Munich Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Munich) |
| Trial ID | NCT04681768 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Abemaciclib in combination with endocrine therapy as a first-line treatment for women with metastatic breast cancer, particularly those with symptomatic visceral metastases or high tumor burden. The study will collect real-world data to confirm the benefits of this treatment approach, focusing on patients with estrogen receptor positive and HER2 negative breast cancer. Abemaciclib, a CDK4/6 inhibitor, has shown promising results in previous trials, and this study seeks to further validate its efficacy in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include female patients aged 18 and older with estrogen receptor positive, HER2 negative metastatic breast cancer who are starting endocrine therapy in combination with Abemaciclib.
Not a fit: Patients with non-hormone receptor positive breast cancer or those who are not starting endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with metastatic breast cancer by enhancing tumor response and prolonging survival.
How similar studies have performed: Previous studies have shown success with CDK4/6 inhibitors like Abemaciclib, indicating a promising approach for this patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Munich
- Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde — Munich, Germany (Recruiting)
Study contacts
- Study coordinator: Johannes Ettl, MD
- Email: johannes.ettl@tum.de
- Phone: :+49-89-4140-2433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.