Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

NCT03220178 | Terminated Phase 4 DMC

• 1 other identifier: PH001-PreCycle
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.

Conditions

Breast Neoplasm

Keywords

breast cancer; HER2 negative; hormone receptor positive; advanced; metastatic

Outcome Measures

Primary Outcomes (1)

• DQoL

  The event "deterioration of quality of life" (DQoL) will be measured every 28 days after enrolment using the FACT-B scale.

  From start of study treatment up to 4 years

Secondary Outcomes (4)

• Progression-free survival

  From start of study treatment up to 4 years

• Overall survival

  From start of study treatment up to 4 years

• Drug intake

  From start of study treatment up to 4 years

• Global health status

  From start of study treatment up to 4 years

Study Arms (2)

CANKADO active

EXPERIMENTAL

CANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome.

Drug: Palbociclib; Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane

CANKADO inform

OTHER

CANKADO inform stands for a CANKADO-based eHealth service with a personal login. For the patient , on-site surveys without feedback functions and a dosing tracker to document daily drug intake will be available. CANKADO inform will be used for the initial ePRO and further on-site ePROs. Patients can login from home, but they will only get text information about their disease and treatment. Further features will be unavailable.

Drug: Palbociclib; Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane

Interventions

Palbociclib DRUG

Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle

CANKADO active; CANKADO inform

Fulvestrant DRUG

500mg per use-after first application, again at wk2, then once per month

CANKADO active; CANKADO inform

Anastrozole DRUG

1mg per day

CANKADO active; CANKADO inform

Letrozole DRUG

2,5mg/day

CANKADO active; CANKADO inform

Exemestane DRUG

25mg/day

CANKADO active; CANKADO inform

Eligibility Criteria

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

You may qualify if:

• Post- or pre/peri-menopausal female patients, age ≥18 years
• Patients with metastatic or locally advanced (non-operable) breast cancer disease
• Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination therapy OR Patients having already received endocrine therapy who are appropriate candidates for fulvestrant+ palbociclib combination therapy
• Patient has not received treatment for locally advanced or metastatic disease OR Patient has received one prior line of chemotherapy and/or a maximum of two endocrine therapy lines for locally advanced or metastatic disease
• Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
• The tumor must be hormone-receptor positive
• The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization..
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate organ and marrow function before palbociclib treatment starts on C1D.
• In case of patients of child bearing potential: negative pregnancy test (urine or serum) at baseline. Patients must agree to use highly effective non-hormonal contraception
• Resolution of all acute toxic effects of prior therapy, including radiotherapy grade \<1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
• Signed Written Informed Consent
• Willingness and capability to use CANKADO
• Availability of hardware: Computer and/or tablet and/or smartphone with internet access

You may not qualify if:

• Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its excipients
• Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists (if pre-menopausal)
• Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
• Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term
• Known active uncontrolled or symptomatic central nervous system metastases
• Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4)
• High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months of enrollment
• Diagnosis of any second malignancy within the last 5 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
• Participation in other clinical trials involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation
• Lactating women
• Life expectancy \< 3 months
• Known infection with HIV, hepatitis B virus, or hepatitis C virus
• Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
• Legal incapacity or limited legal capacity.

Sponsors & Collaborators

• Palleos Healthcare GmbH: lead
• WSG WOMEN´S HEALTHCARE STUDY GROUP: collaborator
• Cankado GmbH: collaborator
• Pfizer: collaborator
• AGO-TraFo: collaborator
• AGO-B: collaborator
• Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.: collaborator

Study Sites (1)

University Hospital Mainz

Mainz, 55131, Germany

Location

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

palbociclib; Fulvestrant; Anastrozole; Letrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Iris Reiser, PhD

  Palleos Healthcare GmbH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 18, 2017
• Study Start: July 24, 2017
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)