PRECYCLE: Multicenter, randomized phase IV intergroup trial to evaluate the impact of e Health-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 - PreCycle
- Conditions
- advanced and or metastatic breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004191-22-DE
- Lead Sponsor
- Palleos healthcare GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 960
Participants are eligible to be included in the study only if all of the following criteria apply:
1.Women 18 years of age or older, who are either:
•Post-menopausal, as defined by at least one of the following criteria:
- Age = 60 years;
- Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or serum
estradiol and FSH level within the laboratory’s reference range for post-menopausal females;
- Documented bilateral oophorectomy;
- Medically confirmed ovarian failure.
OR
- Pre/peri-menopausal, i.e., not meeting the criteria for being postmenopausal.
- Pre/peri-meopausal women can be enrolled if amenable to be treated with a
LHRH-agonist. Patients should be treated with a LHRH-agonist.
2.Patients have to have metastatic disease or locally advanced (non-operable) breast cancer disease.
3.Patients who are appropriate candidates for aromatase inhibitor + palbociclib combination
OR
Patients having already received endocrine therapy who are appropriate candidates for fulvestrant + palbociclib combination therapy
4.Patient has not received prior treatment of 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 LHRH-agonist
6.The tumor has to be hormone-receptor positive (ER-positive and/or PR-positive tumor (= 1% positive stained cells).
7. The tumor has to be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by ISH.
8.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9.Adequate organ and bone marrow function confirmed before palbociclib treatment start on C1D1, evidenced by the following laboratory results below:
- absolute neutrophil count = 1500 cells/µL,
platelet count = 100000 cells/µL,
- hemoglobin = 9 g/dL
- ALT (SGPT) = 2.0 × ULN (= 3.0 × ULN in case of liver metastases)
- AST (SGOT) = 2.0 × ULN (= 3.0 × ULN in case of liver metastases)
- bilirubin = 1.5 × ULN (with the exception of Gilbert’s syndrome)
- creatinine = 2.0 mg/dl or 177µmol/L
10.In case of patients of child bearing potential:
Negative pregnancy test (urine or serum) at baseline (within 7 days prior to randomization). Patient must agree to use highly effective non-hormonal contraceptive methods that result in a failure rate of < 1% per year, (intrauterine device (IUD), bilateral tubal occlusion, vasectomised partner1, sexual abstinence2 ) beginning 2 weeks before the first dose of investigational medicinal product (IMP) and for 2 years after the last dose of study treatment.
11.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
12.Patients who are able and willing to sign the informed consent form
13.Willingness and capability to use CANKADO
14.Availability of hardware: Computer and/or tablet and/or smartphone with internet access
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 640
Participants are excluded from the study if any of the following criteria apply:
1.Known hypersensitivity to aromatase inhibitor, fulvestrant, Palbociclib or any of its excipients
1 Provided that the partner is the sole sexual partner of the patient and that the vasectomised partner has
received medical assessment of the surgical success.
2 Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
2.Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or LHRH-agonists if pre-menopausal
3.Prior treatment with any CDK inhibitor.
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 CNS metastases
6.Current use of food or drugs known to be potent inhibitors or inducers of 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 prior to enrollment.
8.Diagnosis of any second malignancy within the last 3 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 studies 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method