Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
1. Progression Free Survival (PFS) (Time Frame - Time from date of trial registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months): PFS, defined as the time from date of trial registration until progressive disease (PD) or death from any cause, whichever comes first (as defined by RECIST guideline version 1.1). If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Secondary outcome:
1. Adverse Events (Time Frame - From obtaining informed consent until progressive disease (PD) or up to 30 days after end of trial treatment): Adverse Events assessed by investigator (type, frequency, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0)), seriousness)
2. Patient-reported side effects (Time Frame - From first dose of study medication up to 30 days after end of trial treatment): Additional capture of Patient-Reported side effects on a daily basis via CANKADO PRO-React (patient diary).
3. Patient-reported global health status (Time Frame - From first dose of study medication up to 30 days after end of trial treatment): Daily self-assessment of global health status using the visual analogue scale (EQ-VAS, based on the EQ-5D questionnaire) via CANKADO. The EQ-VAS scale ranges from 0 (the worst possible health status to 100 (the best possible health status).
4. Frequency of hospitalizations (Time Frame - Time from date of registration for the trial through study completion (4 years after date of First Patient In)): Frequency of hospitalizations during study treatment
5. Patient reported European Organisation for Research and Treatment of Cancer Quality of Life C30 questionaire (EORTC QLQ-C30) (Time Frame - At baseline, at 3, 6, 9, 12, 18, 24 months): Patient reported quality of life as assessed with the EORTC QLQ-C30 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
6. Patient reported European Organisation for Research and Treatment of Cancer Quality of Life B23 breast cancer module questionaire (EORTC QLQ-BR23) (Time Frame - At baseline, at 3, 6, 9, 12, 18, 24 months): Patient reported quality of life as assessed with the EORTC QLQ-BR23 questionnaire. The QLQ-B23 breast cancer module incorporates five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
7. Clinical benefit rate (CBR) (Time Frame - Time from date of registration for the trial until 24 weeks of study treatment): CBR defined as percentage of patients with complete response, partial response or stable disease
8. Overall Survival (OS) (Time Frame - Time from date of trial registration until date of death due to any cause, assessed up to 48 months): Overall survival (OS) defined as the time from date of trial registration until date of death due to any cause. If a patient is not known to have died, survival is censored at the date of last contact.
9. Objective Response Rate (ORR) (Time Frame - Time from date of registration for the trial through study completion (4 years after date of First Patient In)): ORR defined as percentage of patients with complete or partial response as defined by RECIST 1.1
10. Number of patients with primary progression (Time Frame - Time from date of registration for the trial until first imaging after 12 weeks): Number of patients with primary progression, defined as number of patients with disease recurrence within 12 weeks after recruitment.
Experimental: Abemaciclib + Aromatase-Inhibitor The patients will receive Abemaciclib in combination with an Aromatase-Inhibitor (either Anastrozole, Letrozole or exemestane)
Experimental: Abemaciclib + Fulvestrant The patients will receive Abemaciclib in combination Fulvestrant
Abemaciclib + Aromatase Inhibitor (Verzenios): Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)
Abemaciclib + Fulvestrant (Verzenios): Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)
Quelle: ClinicalTrials.gov
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