Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

• Status: Active, not recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palleos Healthcare GmbH
• Collaborators: AGO-B; AGO-TraFo; CANKADO; Cankado Service GmbH; Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.; Pfizer; WSG WOMEN´S HEALTHCARE STUDY GROUP
• Treatments: Anastrozole; Exemestane; Fulvestrant; Letrozole; Palbociclib

Criteria

Inclusion Criteria:

1. Post- or pre/peri-menopausal female patients, age ≥18 years

2. Patients with metastatic or locally advanced (non-operable) breast cancer disease

3. Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination therapy OR Patients having already received endocrine therapy who are appropriate candidates for fulvestrant+ palbociclib combination therapy

4. Patient has not received treatment for locally advanced or metastatic disease OR Patient has received one prior line of chemotherapy and/or a maximum of two endocrine therapy lines for locally advanced or metastatic disease

5. Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..

6. The tumor must be hormone-receptor positive

7. The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization..

8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

9. Adequate organ and marrow function before palbociclib treatment starts on C1D.

10. In case of patients of child bearing potential: negative pregnancy test (urine or serum) at baseline. Patients must agree to use highly effective non-hormonal contraception

11. Resolution of all acute toxic effects of prior therapy, including radiotherapy grade <1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures

12. Signed Written Informed Consent

13. Willingness and capability to use CANKADO

14. Availability of hardware: Computer and/or tablet and/or smartphone with internet access

Exclusion Criteria:

1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its excipients

2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists (if pre-menopausal)

3. Prior treatment with any inhibitor of cyclin dependent kinase (CDK).

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 central nervous system metastases

6. Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome P450 3A4 (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 of enrollment

8. Diagnosis of any second malignancy within the last 5 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 clinical trials 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.