COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

• Register: LBCTR
• Last refreshed on: 30 August 2021
• Main ID: LBCTR2019010184
• Date of registration: 27/01/2021
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services Inc.
• Public title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
• Scientific title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
• Date of first enrolment: 10/08/2018
• Target sample size: 20
• Recruitment status: Complete
• URL: https://lbctr.moph.gov.lb/Trials/Details/4726
• Study type: Interventional
• Study design: Allocation: N/A: Single arm study;Masking: Open (masking not used);Control: N/A;Assignment: Single;Purpose: Treatment
• Phase: 3

Countries of recruitment

Argentina, Austria, Belgium, Bulgaria, Canada, Jordan, Lebanon, Oman, Saudi Arabia, Spain, United Kingdom, United States of America

Contacts

• Name: Hind Khairallah
• Affiliation: Khalil Fattal et Fils s.a.l.

• Name: Fadi Farhat
• Affiliation: Hammoud Hospital

Key inclusion & exclusion criteria

Inclusion criteria: •Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.

•In the case of women, both pre/perimenopausal and postmenopausal patients are eligible

•Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer

•Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required

•Patient has an Eastern Cooperative Oncology Group (ECOG) performance status =2

•Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
?Absolute neutrophil count = 1.5 × 10^9/L
?Platelets = 100 × 10^9/L
?Hemoglobin = 9.0 g/dL
?Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
?INR =1.5
?Serum creatinine <1.5 mg/dl or creatinine clearance=50 mL/min
?In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
?Total serum bilirubin < ULN; or total bilirubin = 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome

•Patient must have a 12-lead ECG with ALL of the following parameters at screening:
?QTcF interval at screening <450 msec (using Fridericia's correction)
?Resting heart rate = 50 bpm
Exclusion criteria: •Patient who received any CDK4/6 inhibitor
•Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted

Age minimum: 18
Age maximum: 99
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Breast Cancer
Breast Cancer

Breast Cancer

C50.9

Intervention(s)

•Drug: Ribociclib
•Drug: Letrozole
•Drug: Goserelin

Lab tests , ECG , Radiology assessment

Lab tests , Radiology , ECG

Primary Outcome(s)

Name: The number of participants with adverse events as a measure of safety and tolerability;Timepoints: PFS;Measure: Progression free survival

Secondary Outcome(s)

Name: Time-to-Progression (TTP), Overall response rate (ORR), , Clinical Benefit Rate (CBR);Timepoints: PFS;Measure: Progression free survival

Secondary ID(s)

NCT02941926

Source(s) of Monetary Support

Novartis Pharma Services Inc.

Ethics review

Status: Approved
Approval date: 02/05/2017
Contact:

[e-mail]

Hotel Dieu de France

961421229

[e-mail]

Status: Approved
Approval date: 02/05/2017
Contact:

[e-mail]

Hammoud Hospital University Medical Center

961 (0) 7 723111 ext 1160

[e-mail]

Status: Approved
Approval date: 21/08/2017
Contact:

[e-mail]

Bellevue Medical Center

961 (0) 1 682666 ext 5006

[e-mail]

Results

• Date Completed: 12/01/2018