Clinical trial NCT04985058: Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
Official title: Real-world Clinical Outcome and Toxicity Data in Patients With Breast Cancer Treated With Abemaciclib Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: abemaciclib
real-world data
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy

Brief summary: The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.

Detailed description: Protocol was amended in November 2021, after the recent FDA approval of abemaciclib in the adjuvant setting. On October 12, 2021, FDA approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%. Our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well. 2-negative advanced breast cancer. Patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform (CARE ACROSS platform) where they can register their side-effects of cancer and the treatment received at frequent intervals. Patients will be randomized in the platform in two arms with an allocation 1:1(automatically by the platform). After every report of their side-effects, patients in Arm A will receive an acknowledgement and suggestion to stay in contact with their clinician. After every report of their side- effects, patients in Arm B will receive an acknowledgment and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported. Clinicians involved in the trial will refer patients (upon enrollment or to those already enrolled) to a dedicated online platform. Patients will sign up by entering their patient ID and their email address (and picking their password for security).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed HR-positive, HER2-negative breast cancer
* Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
* 18 years or older
* Any menopausal status
* Treatment with abemaciclib in combination with endocrine therapy
* Any endocrine therapy
* At least two months of treatment with abemaciclib

Primary outcomes:
measure: Progression-free survival
timeFrame: Through the completion of the study, for an average of 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months
measure: Efficacy of the digital support through personalised support in patients with BC
timeFrame: Up to 30 months
measure: Toxicity rate
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Oncology Cooperative Group
Study officials:
References: