ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03220178
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
WSG WOMEN´S HEALTHCARE STUDY GROUP
CANKADO
Pfizer
AGO-TraFo
AGO-B
Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.
Information provided by (Responsible Party):
Palleos Healthcare GmbH

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Palbociclib Drug: Fulvestrant Drug: Anastrozole Drug: Letrozole Drug: Exemestane Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: CANKADO active
CANKADO active is the fully functional CANKADO-based eHealth treatment support service, including a high density observation of patient reported outcome.
Drug: Palbociclib
Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle

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

Drug: Anastrozole
1mg per day

Drug: Letrozole
2,5mg/day

Drug: Exemestane
25mg/day

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

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

Drug: Anastrozole
1mg per day

Drug: Letrozole
2,5mg/day

Drug: Exemestane
25mg/day




Primary Outcome Measures :
  1. DQoL [ Time Frame: From start of study treatment up to 4 years ]
    The event "deterioration of quality of life" (DQoL) will be measured every 28 days after enrolment using the FACT-B scale.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From start of study treatment up to 4 years ]
    Progression-free survival (PFS) is considered to be the main clinical outcome and is defined as the time between treatment allocation and either first documentation of objective progression of disease (PD), as assessed by Investigator or death due to any cause in absence of PD.

  2. Overall survival [ Time Frame: From start of study treatment up to 4 years ]
    Overall survival (OS) is defined as the time between treatment allocation and death due to any cause.

  3. Drug intake [ Time Frame: From start of study treatment up to 4 years ]
    Daily electronic documentation of dosage and time of drug intake.

  4. Global health status [ Time Frame: From start of study treatment up to 4 years ]
    Daily electronic rating of overall health-related quality of life on a visual analogue scale (EQ-VAS) between 100 (best health imaginable) and 0 (worst health imaginable).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Post- or pre/peri-menopausal female patients, age ≥18 years
  2. Patients with metastatic or locally advanced (non-operable) breast cancer disease
  3. 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
  4. 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
  5. Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
  6. The tumor must be hormone-receptor positive
  7. The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization..
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  9. Tissue of the primary tumor and metastatic lesion for biomarker study if applicable
  10. Adequate organ and marrow function
  11. In case of patients of child bearing potential: negative serum pregnancy test at baseline. Patients must agree to use highly effective non-hormonal contraception
  12. 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
  13. Signed Written Informed Consent
  14. Willingness and capability to use CANKADO
  15. Availability of hardware: Computer and/or tablet and/or smartphone with internet access

Exclusion Criteria:

  1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its excipients
  2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists (if pre-menopausal)
  3. Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
  4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at risk of life threatening complications in the short term
  5. Known active uncontrolled or symptomatic central nervous system metastases
  6. Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4)
  7. 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
  8. 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
  9. 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
  10. Lactating women
  11. Life expectancy < 3 months
  12. Known infection with HIV, hepatitis B virus, or hepatitis C virus
  13. 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
  14. Legal incapacity or limited legal capacity.

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): NCT03220178


Contacts
Contact: Palleos Healthcare GmbH 0049611 950 190 ext 0 info@palleos.com

Locations
Germany
University Hospital Mainz Recruiting
Mainz, Germany, 55131
Contact: Marcus Schmidt, Prof. Dr.         
Sponsors and Collaborators
Palleos Healthcare GmbH
WSG WOMEN´S HEALTHCARE STUDY GROUP
CANKADO
Pfizer
AGO-TraFo
AGO-B
Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.
Investigators
Study Director: Iris Reiser, PhD Palleos Healthcare GmbH

Publications:
Finn RS, Martin M, Rugo HS, Jones SE, Im SA, Gelmon KA, Harbeck N, Lipatov ON, Walshe JM, Moulder SL, Gauthier ER, Lu D, Randolph S, Diéras V, Slamon DJ. PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in post-menopausal women with ER+/HER2- advanced breast cancer (ABC). J Clin Oncol 34, 2016 (suppl; abstr 507)
Harbeck, N., R. Wuerstlein and T. Schinkoethe (2015).
Kalbfleisch, J.D., Prentice, R. L. (2002). "The statistical analysis of failure time data" (2nd Ed.) John Wily & Sons, p. 224
Schoenfeld, D. A., Tsiatis, A. A. (1987)."A modified log rank test for highly stratified data." Biometrika, 167-175

Responsible Party: Palleos Healthcare GmbH
ClinicalTrials.gov Identifier: NCT03220178     History of Changes
Other Study ID Numbers: PH001-PreCycle
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Palleos Healthcare GmbH:
breast cancer
HER2 negative
hormone receptor positive
advanced
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Fulvestrant
Palbociclib
Exemestane
Anastrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Protein Kinase Inhibitors