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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).

NCT03355157

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: 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).
  • Official Title: 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).

Clinical Trial IDs

  • ORG STUDY ID: GBG 93
  • SECONDARY ID: 2016-004482-89
  • NCT ID: NCT03355157

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)Chemotherapy +/- endocrine maintenance therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Palbociclib + endocrine therapyExperimentalExperimental arm for testing palbociclib + endocrine therapy.
  • Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Chemotherapy +/- endocrine maintenance therapyActive ComparatorChemotherapy +/- endocrine maintenance as comparator arm.
  • Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. Female or male patients.

          3. Age ≥ 18 years old.

          4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer
             (histologically confirmed).

          5. 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.

          6. Symptomatic or asymptomatic metastatic breast cancer.

          7. 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).

          8. Life-expectancy > 6 months.

          9. 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:

          1. Indication for poly-chemotherapy or single-agent endocrine therapy only or
             bevacizumab.

          2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.

          3. Uncontrolled/untreated central nervous system lesions.

          4. Patients who received treatment for metastatic/relapsed breast cancer.

          5. Inadequate organ function as per physician's assessment immediate prior to
             randomization.

          6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to
             randomization and/or concurrent use.

          7. Known severe hypersensitivity reactions to compounds or excipients similar to
             palbociclib, planned chemotherapy or planned endocrine therapy.

          8. Existing contraindication against the use of palbociclib, planned chemotherapy or
             planned endocrine therapy.

          9. Patients with hereditary problems of galactose intolerance, the Lapp lactase
             deficiency, and glucose-galactose malabsorption.

         10. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time-to-treatment failure (TTF)
Time Frame:31 months
Safety Issue:
Description:To compare the time-to-treatment failure (TTF) for patients randomized to receive pre-defined chemotherapy treatment strategy versus those randomized to receive palbociclib and endocrine therapy.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:German Breast Group

Trial Keywords

  • Palbociclib
  • Endocrine Therapy
  • Chemotherapy
  • Real world setting
  • Electronic patient-reported outcome
  • Daily Monitoring Treatment Impact
  • Health care utilization (call tracking, geofencing)

Last Updated

September 18, 2018