The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease. MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and u
Conditions
Interventions
Trade Name: Kisqali
Pharmaceutical Form: Tablet
INN or Proposed INN: RIBOCICLIB
CAS Number: 1211441-98-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharm
Sponsors
iOMEDICO AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Locally confirmed diagnosis of metastatic adenocarcinoma of the breast without prior systemic antineoplastic therapy in the palliative setting. • Hormone receptor (HR)-positive disease, defined as estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive. • Human epidermal growth factor receptor 2 (HER2)-negative disease (defined as IHC status HER2 negative/+ or IHC HER2++ with CISH/FISH negative). • Any menopausal status. If pre-/perimenopausal, agreement to receive LHRH (goserelin or leuprorelin) agonist / ovarian ablation in case of randomization to arm A. • Women with child bearing potential must agree to use an effective method of contraception while taking study medication and for the time-period indicated in the respective SmPC thereafter. • Presence of visceral metastases (additional non-visceral metastases are allowed). • Presence of target and / or non-target lesions according to RECIST v1.1 • Patients eligible for palliative treatment with AI / fulvestrant + ribociclib and capecitabine + bevacizumab or paclitaxel + / - bevacizumab according to the respective SmPCs. • Signed written informed consent prior to beginning of protocol-specific procedures. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Any prior systemic palliative therapy • Prior treatment with any CDK4/6 inhibitor. • Prior adjuvant or neoadjuvant taxane therapy if last application within 12 months prior to entering the study. • Patient is concurrently using other anti-cancer therapy. • Patient has had major surgery within 28 days prior to randomization or has not recovered from major side effects or wound is not fully recovered. • Patient has received extended-field radiotherapy = 4 weeks or limited-field radiotherapy = 2 weeks prior to randomization. • Known hypersensitivity to ribociclib, AI, fulvestrant, paclitaxel, capecitabine, bevacizumab or any of their excipients, or against peanut, soya, CHO cell products or macrogolglycerol ricinoleate-35. • Participation in prior investigational studies within 30 days prior to randomization or within 5-half lives of the investigational product, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: - To assess and compare the two treatment arms with respect to the following efficacy outcomes: response rates, clinical benefit rate (CBR), time to response (TTR) and overall survival (OS). - To determine safety and tolerability in the two treatment arms in terms of (S)AEs, ECOG performance status, routine safety laboratory and electrocardiogram. - To evaluate and compare patient reported health-related QoL in terms of EORTC QLQ-C30 scores and single questions on burden by side effects and time spent on treatment in the two treatment arms.;Main Objective: To compare the efficacy in terms of progression free survival (PFS) of ribociclib plus endocrine therapy with capecitabine with bevacizumab or paclitaxel with or without bevacizumab as first-line treatment of adult women with HR-positive, HER2-negative advanced breast cancer presenting with visceral metastasis. ;Primary end point(s): PFS assessed by local investigator using RECIST v1.1 criteria. PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy. ;Timepoint(s) of evaluation of this end point: Study data will be analyzed in one final analysis, based on the current number of randomized patients. The final analysis will be performed after end of study and will provide data on all endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Efficacy: • ORR (complete or partial response) assessed by the local investigator according to RECIST v1.1. • CBR (complete or partial response or stable disease lasting 24 weeks or more) assessed by the local investigator according to RECIST v1.1. • TTR (time from randomization to first occurrence of any response (complete or partial)) assessed by the local investigator according to RECIST v1.1 • OS, defined as time from randomization to death of any cause Safety and tolerability: • (S)AEs, frequency and severity graded according to CTCAE v4.03 until 30 days after EOT • ECOG performance status • Routine safety laboratory until EOT • Electrocardiogram (QTc time) until EOT Patient-reported outcomes in QoL: • Quality of Life over time and change from baseline in the global health scale and all functional and symptom scores of the EORTC QLQ C30 • Burden by side effects of treatment at all questionnaire time points (single item) • Burden by time spent on treatment at all questionnaire time points (four single item);Timepoint(s) of evaluation of this end point: Study data will be analyzed in one final analysis, based on the current number of randomized patients. The final analysis will be performed after end of study and will provide data on all endpoints. | — |
Countries
Germany
Contacts
Public ContactDr. Beate Niemeier
iOMEDICO AG
Outcome results
None listed