NCT03220178: PRECYCLE

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

Terminated Phase 4 Last updated 6 January 2022

What this trial tests

Phase 4 trial testing Palbociclib in Breast Neoplasm in 532 participants. Terminated before completion.

Timeline

24 July 2017

Primary endpoint
7 December 2021

7 December 2021

Quick facts

Lead sponsor	Palleos Healthcare GmbH
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	532
Start date	24 July 2017
Primary completion	7 December 2021
Estimated completion	7 December 2021
Sites	1 location across Germany

Drugs / interventions tested

• Palbociclib (Palbociclib) — full drug profile →
• Fulvestrant (fulvestrant) — full drug profile →
• Anastrozole (anastrozole) — full drug profile →
• Letrozole — full drug profile →
• Exemestane

Conditions studied

• Breast Neoplasm — all drugs for Breast Neoplasm →

Sponsor

Palleos Healthcare GmbH — full company profile →

Who can join

18 and older, female only, with Breast Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CDK4 and CDK6 kinases: From basic science to cancer therapy.
   Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
2. Mechanisms of resistance in estrogen receptor positive breast cancer: overcoming resistance to tamoxifen/aromatase inhibitors.
   Mills JN, Rutkovsky AC, Giordano A. · · 2018 · cited 99× · PMID 29719270 · DOI 10.1016/j.coph.2018.04.009
3. Chemoresistance in breast cancer: PI3K/Akt pathway inhibitors vs the current chemotherapy.
   Kaboli PJ, Imani S, Jomhori M, Ling KH. · · 2021 · cited 51× · PMID 34765318
4. The Renaissance of Cyclin Dependent Kinase Inhibitors.
   Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293
5. Latest Overview of the Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: The Past, the Present and the Future.
   Chen X, Xu D, Li X, Zhang J, et al · · 2019 · cited 37× · PMID 31777590 · DOI 10.7150/jca.33079
6. Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2- metastatic breast cancer patients receiving palbociclib and endocrine therapy: primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial.
   Harbeck N, Fasching PA, Wuerstlein R, Degenhardt T, et al · · 2023 · cited 30× · PMID 37201751 · DOI 10.1016/j.annonc.2023.05.003
7. Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results.
   Lantzsch H, Eckhardt H, Campione A, Busse R, et al · · 2022 · cited 27× · PMID 36131288 · DOI 10.1186/s12913-022-08500-6
8. CDK4/6 Inhibitors in Advanced HR+/HER2 - Breast Cancer: A Multicenter Real-World Data Analysis.
   Müller C, Kiver V, Solomayer EF, Wagenpfeil G, et al · · 2023 · cited 26× · PMID 36876172 · DOI 10.1159/000527917