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fortgeschrittenes Mammakarzinom

PreCycle

Multicenter, randomized phase IV
intergroup trial to evaluate the impact of
e Health-based patient reported outcome (PRO)
assessment on quality of life in patients with
hormone receptor positive, HER2 negative
locally advanced or metastatic breast cancer
treated with Palbociclib and an aromatase
inhibitor- or Palbociclib and Fulvestrant

Erkrankung: Brustkrebs (Mammakarzinom)
Status der Studie: Studie rekrutiert
Studiendesign: interventionell
Studienphase: Phase IV
Studienart: Medikamentöse Therapie
Haupteinschlusskritieren: 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
Hauptausschlusskritieren: 1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or
any of its excipients
2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or
LHTH-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
Prüfarzt: Dr. med. Antje Lehnert
Weitere Informationen: Impact of eHealth-support on Quality of Life in metastatic breast cancer patients treated with Palbociclib and endocrine therapy

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