advanced and or metastatic breast cancer
Conditions
Interventions
Trade Name: IBRANCE 125mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PALBOCICLIB
CAS Number: 571190-30-2
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Palleos healthcare GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Women 18 years of age or older, who are either: • Post-menopausal, as defined by at least one of the following criteria: - Age = 60 years; - Age =65 years) yes F.1.3.1 Number of subjects for this age range 640
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Known hypersensitivity to aromatase inhibitor, fulvestrant, Palbociclib or any of its excipients 1 Provided that the partner is the sole sexual partner of the patient and that the vasectomised partner has received medical assessment of the surgical success. 2 Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. 2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or LHRH-agonists if pre-menopausal 3. Prior treatment with any CDK inhibitor. 4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term 5. Known active, uncontrolled or symptomatic CNS metastases 6. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 7. High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months prior to enrollment. 8. Diagnosis of any second malignancy within the last 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 9. Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation. 10. Lactating women 11. Life expectancy < 3 months 12. Known infection with HIV, hepatitis B virus, or hepatitis C virus 13. Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient’s adherence to the protocol 14. legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • TTD (time to deterioration) with respect to DQoL (deterioration of quality of life as a 10-point drop on FACT-G) Time to deterioration (TTD) with respect to DQoL is defined as the difference between time of treatment allocation (randomization) and time of DQoL. Patients not meeting deterioration criteria are to be censored at death or a maximum of 48 months of follow-up after treatment allocation. The event “deterioration of quality of life” (DQoL) is defined as any decrease of 10 or more points from baseline in QoL as assessed using the FACT-G scale, unless a recovery is achieved in the subsequent assessment. A recovery is defined as a QoL score no worse than 9 points below baseline. If data of the subsequent visit is missing, a decrease of 10 or more points will be considered as event. The definition of DQoL as a 10-point decrease on the FACT-G scale is based on Cella et al. (2002) and corresponds to a mean change from baseline in a subgroup of various cancer patients who classified the change as “minimally worse” according to a global rating of change (GRC) scale administered immediately after the FACT-G. Note that Eton et al. (2004) also suggested a 5-6 points change on FACT-G as minimally important difference (MID) in metastatic breast cancer patients. It is expected that the conservative choice of a 10-point decrease will be more robust against less meaningful fluctuations of the QoL measurement time series in the context of the precycle trial. A definition of DQoL in terms of MID (5-point decrease on FACT-G) will be used for sensitivity analyses in a dedicated secondary objective.;Main Objective: To demonstrate superiority w.r.t. time to deterioration (TTD) of quality of life for patients with eHealth-based high density observation using CANKADO (CANKADO active) versus eHealth-based static observation on site (CANKADO inform).;Secondary Objective: i. Sensitivity Analysis: To compare TTD DQoL between the two treatment arms in terms | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objectives: i. Sensitivity Analysis: To compare TTD DQoL between the two treatment arms in terms of DQoL as minimally important difference (5-point drop on FACT-G). ii. To demonstrate that an eHealth-based high density observation using CANKADO does not have a negative impact on clinical outcome (PFS, OS). iii. To analyze the effect of patient reported outcome (PRO; data of daily drug intake behavior, global health status, quality of life) w.r.t. clinical outcome (PFS, OS) and DQoL. Endpoints: • PFS (progression-free survival) • OS (overall survival) • DQoL (deterioration of quality of life) Progression-free survival (PFS) is considered to be the main clinical outcome and is defined as the time between treatment allocation and either first documentation of objective progression of disease (PD, as assessed by Investigator) or death due to any cause in absence of PD. Overall survival is defined as the time between treatment allocation and death due to any cause. The event “deterioration of quality of life” (DQoL) is defined as any decrease of 10 or more points from baseline in QoL as assessed using the FACT-G scale, unless a recovery is achieved in the subsequent assessment. A recovery is defined as a QoL score no worse than 9 points below baseline. If data of the subsequent visit is missing, a decrease of 10 or more points will be considered as event. The definition of DQoL as a 10-point decrease on the FACT-G scale is based on Cella et al. (2002) and corresponds to a mean change from baseline in a subgroup of various cancer patients who classified the change as “minimally worse” according to a global rating of change (GRC) scale administered immediately after the FACT-G. Note that Eton et al. (2004) also suggested a 5-6 points change on FACT-G as minimally important difference (MID) in metastatic breast cancer patients. It is expected that the conservative choice of a 10-point decrease will be more robust against less meaning | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Palleos healthcare GmbH
Outcome results
None listed