CompletedPhase 4

A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).

Germany130 participantsStarted 2018-03-01

Plain-language summary

The goal of the study for patients with metastatic breast cancer (MBC) is to show that palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure over chemotherapy regimen (mono-chemotherapy with or without endocrine therapy). This would provide level 1 evidence from real world that palbociclib plus endocrine therapy is the first choice in MBC patients needing first-line therapy not only compared to endocrine therapy but also compared to chemotherapy with or without endocrine maintenance therapy. In addition, we assume that patient-reported outcome as measured by FACT-B and a novel composite endpoint of well-being and healthcare utilization (DMTI) will be improved with palbociclib + endocrine treatment vs. chemotherapy regimen.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via wearable device and study mobile must be obtained and documented according to the local regulatory requirements.
✓. Female or male patients.
✓. Age ≥ 18 years old.
✓. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).
✓. Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.
✓. Symptomatic or asymptomatic metastatic breast cancer.
✓. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
✓. Life-expectancy \> 6 months.

Exclusion criteria

What they're measuring

Time-to-treatment failure (TTF)

Timeframe: 31 months

Trial details

NCT IDNCT03355157

SponsorGBG Forschungs GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

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