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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). (PADMA)

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ClinicalTrials.gov Identifier: NCT03355157
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborators:
Pfizer
Advanced Medical Services
Information provided by (Responsible Party):
German Breast Group

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 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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Palbociclib + endocrine therapy
Experimental arm for testing palbociclib + endocrine therapy.
Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Drug intervention

Active Comparator: Chemotherapy +/- endocrine maintenance therapy
Chemotherapy +/- endocrine maintenance as comparator arm.
Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Drug intervention




Primary Outcome Measures :
  1. Time-to-treatment failure (TTF) [ Time Frame: 31 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355157


Contacts
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Contact: Mathias Uhlig, PhD 49-6102-7480 ext 414 mathiasuhlig@gbg.de

Locations
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Germany
Agaplesion Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe Recruiting
Frankfurt am Main, Germany, 60431
Contact: Marc Thill, MD, PhD       marc.thill@fdk.info   
Sponsors and Collaborators
German Breast Group
Pfizer
Advanced Medical Services
Investigators
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Study Chair: Sibylle Loibl, MD, PhD German Breast Group - GBG Forschungs GmbH

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Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT03355157     History of Changes
Other Study ID Numbers: GBG 93
2016-004482-89 ( EudraCT Number )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by German Breast Group:
Palbociclib
Endocrine Therapy
Chemotherapy
Real world setting
Electronic patient-reported outcome
Daily Monitoring Treatment Impact
Health care utilization (call tracking, geofencing)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Vinorelbine
Capecitabine
Letrozole
Epirubicin
Fulvestrant
Palbociclib
Exemestane
Hormones
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal