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

Last updated date
Study Location
Agaplesion Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, , 60431, Germany
Contact
49-6102-7480

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Drug intervention
Study Arms  ICMJE
  • Experimental: Palbociclib + endocrine therapy
    Experimental arm for testing palbociclib + endocrine therapy.
    Intervention: Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
  • Active Comparator: Chemotherapy +/- endocrine maintenance therapy
    Chemotherapy +/- endocrine maintenance as comparator arm.
    Intervention: Drug: Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
150
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
360
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Konstantin Reißmüller49-6102-7480 ext 438[email protected]
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355157
Other Study ID Numbers  ICMJE GBG 93
2016-004482-89 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party German Breast Group
Study Sponsor  ICMJE German Breast Group
Collaborators  ICMJE
  • Pfizer
  • AMS Advanced Medical Services GmbH
Investigators  ICMJE
Study Chair:Sibylle Loibl, MD, PhDGerman Breast Group - GBG Forschungs GmbH
PRS Account German Breast Group
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP