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).

G

German Breast Group (GBG) Research

Status and phase

Enrolling
Phase 4

Conditions

Metastatic Breast Cancer

Treatments

Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03355157
GBG 93
2016-004482-89 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Palbociclib + endocrine therapy
Experimental group
Description:
Experimental arm for testing palbociclib + endocrine therapy.
Treatment:
Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Chemotherapy +/- endocrine maintenance therapy
Active Comparator group
Description:
Chemotherapy +/- endocrine maintenance as comparator arm.
Treatment:
Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Trial contacts and locations

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Central trial contact

Konstantin Reißmüller

Data sourced from clinicaltrials.gov

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