Status:
COMPLETED
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).
Lead Sponsor:
GBG Forschungs GmbH
Collaborating Sponsors:
Pfizer
AMS Advanced Medical Services GmbH
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 re...
Eligibility Criteria
Inclusion
- 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.
- For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).
Exclusion
- Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.
- Asymptomatic oligometastases of the bone as the only site of metastatic disease.
- Uncontrolled/untreated central nervous system lesions.
- Patients who received treatment for metastatic/relapsed breast cancer.
- Inadequate organ function as per physician's assessment immediate prior to randomization.
- Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.
- Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.
- Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.
- Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.
- Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03355157
Start Date
March 1 2018
End Date
August 30 2024
Last Update
October 1 2024
Active Locations (1)
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1
Agaplesion Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Germany, 60431