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 | Completed Phase 4 DMC

• 2 other identifiers: GBG 932016-004482-89
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time-to-treatment failure (TTF)

  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.

  31 months

Study Arms (2)

Palbociclib + endocrine therapy

EXPERIMENTAL

Experimental arm for testing palbociclib + endocrine therapy.

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

Chemotherapy +/- endocrine maintenance therapy

ACTIVE COMPARATOR

Chemotherapy +/- endocrine maintenance as comparator arm.

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

Interventions

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

Drug intervention

Chemotherapy +/- endocrine maintenance therapy; Palbociclib + endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GBG Forschungs GmbH: lead
• Pfizer: collaborator
• AMS Advanced Medical Services GmbH: collaborator

Study Sites (1)

Agaplesion Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, 60431, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Acceptance of Health Care

Interventions

palbociclib; Drug Therapy; Capecitabine; Epirubicin; Paclitaxel; Vinorelbine; exemestane; Fulvestrant; Letrozole; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Triazoles; Azoles; Stilbenes; Benzylidene Compounds; Benzene Derivatives

Study Officials

• Sibylle Loibl, MD, PhD

  German Breast Group - GBG Forschungs GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: March 1, 2018
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)