Metastatic breast cancer. MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 27.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IBRANCE
Product Name: Palbociclib
Product Code: PD-0332991-00
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PALBOCICLIB
Current Sponsor code: PD-0332991-00
Concentration unit: mg
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 study mobile must be obtained and documented according to the local regulatory requirements. 2. Female or male patients. 3. Age = 18 years old. 4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed). 5. 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. 6. Symptomatic or asymptomatic metastatic breast cancer. 7. 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). 8. Life-expectancy > 6 months. 9. 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). 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab. 2. Asymptomatic oligometastases of the bone as the only site of metastatic disease. 3. Uncontrolled/untreated central nervous system lesions. 4. Patients who received treatment for metastatic/relapsed breast cancer. 5. Inadequate organ function as per physician’s assessment immediate prior to randomization. 6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use. 7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy. 8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy. 9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: • To compare progression free survival (PFS) between treatment arms. • To compare time to first subsequent treatment (TFST). • To compare time to first subsequent chemotherapy (TFSCT). • To compare time to second subsequent treatment regimen (TSST). • To compare the overall survival between treatment arms. • To compare patient well-being and health care utilization by daily monitoring treatment impact (DMTI) content with Quality of Life (QoL) and degree of bother by side-effects, number and duration of phone calls, and patient visits to investigator sites. • To compare patient reported outcomes, measured by FACT-B. • To compare time-to-deterioration in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB derived from FACT-B). • To compare safety and tolerability between the two arms. • To compare treatment compliance between the two arms.;Primary end point(s): Time-to-treatment failure (TTF) is defined as time from randomization to discontinuation of treatment due to disease progression, treatment toxicity, patient’s preference, or death. ;Timepoint(s) of evaluation of this end point: 60 months after first patient randomised | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival is defined as the time from randomization to first progression as assessed by the investigator or death, whichever occurs first. • Time to first subsequent treatment (TFST) is defined as the time from randomization to start of first subsequent anti-cancer treatment or death. • Time to first subsequent chemotherapy (TFSCT) is defined as the time from randomization to start of first subsequent anticancer chemotherapy or death. • Time to second subsequent treatment regimen (TSST) is defined as the time from randomization to start of second subsequent treatment regimen or death. • Overall survival is defined as the time from randomization to death due to any reason. • Safety and tolerability (safety by toxicity grades is defined by the NCI CTCAE version 4.0). • Treatment compliance defined as treatment reductions, delays or permanent discontinuation of treatment. The reason for termination includes aspects of efficacy (i.e. termination due to tumor relapse), safety (i.e. termination due to adverse events) and compliance (i.e. termination due to patient's withdrawal of consent). • Patient-reported breast cancer-specific quality of life. • Time-to-deterioration (TTD) in TOI-PFB (FACT-B) is defined as an increase of 5 or more score points from baseline. • Content with QoL and degree of bother by side-effects measured by two daily FACT-derived questions on a 5-point scale for level of Agreement. • Number and duration of phone calls, and patients visits to investigator sites.;Timepoint(s) of evaluation of this end point: 60 months after first patient randomised | — |
Countries
Germany, Spain
Contacts
Public ContactPADMA
GBG Forschungs GmbH
Outcome results
None listed