LBCTR : Trial details

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

Current status: Approved | Date registered: 17/12/2019

History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 History: 11/01/2019 Current: 11/01/2019

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Main Information

Primary registry identifying number

LBCTR2019010184

Protocol number

CLEE011A2404

MOH registration number

20521/2017

Trial already registered with the MoPH

Study registered at the country of origin

Type of registration

Retrospective

Type of registration: Justify

LCTR was already initiated, original file was previously submitted by Paper

Date of registration in national regulatory agency

01/06/2017

Primary sponsor

Novartis Pharma Services Inc.

Primary sponsor: Country of origin

Novartis Pharmaceuticals

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

Acronym

COMPLEEMENT 1

Scientific title

Acronym

Brief summary of the study: English

The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.

Brief summary of the study: Arabic

دراسة مفتوحة اللصاقة، متعددة المراكز في المرحلة الثالثة ب لتقييم سلامة وفعاليّة ريبوسيكليب (LEE011) بالاشتراك مع ليتروزول لعلاج الرجال والنساء قبل/بعد انقطاع الطمث المصابين بسرطان الثدي المتقدّم الإيجابيّ مستقبلات الهرمون (HR+) وسلبيّ الهير 2 (HER2-) الذين لم يتلقوا أي علاج هرمونيّ سابق للمرض المتقدّم

Health conditions/problem studied: Specify

Advanced Breast Cancer

Interventions: Specify

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

Key inclusion and 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

Key inclusion and exclusion criteria: Gender

Both

Key inclusion and exclusion criteria: Age minimum

Key inclusion and exclusion criteria: Age maximum

Key inclusion and exclusion criteria: 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

Type of Study

Type

Interventional

Type of intervention

Pharmaceutical

Trial scope

Therapy

Trial scope: Specify scope

Study design: Allocation

N/A: Single arm study

Study design: Masking

Open (masking not used)

Study design: Control

N/A

Study phase

Study design: Purpose

Treatment

Study design: Assignment

Single

IMP has market authorization

Yes, Lebanon and Worldwide

IMP has market authorization: Specify the countries

USA, EU & other countries

Name of IMP

Ribociclib ( Kisqali)

Year of authorization

2017

Month of authorization

Type of IMP

Others

Type of IMP: Specify

Endocrin based therapy: CDK4/6 inhibitor

Pharmaceutical class

Orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).

Therapeutic indication

Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer

Therapeutic benefit

increase Overall survival and progression free survival

Biospecimen retention

None retained

Biospecimen description

Local lab is being used, no samples will be shipped outside Lebanon, Lab samples are mainly CBC, Chemistry to follow up on patient safety

Target sample size

Actual enrollment target size

Date of first enrollment: Type

Actual

Date of first enrollment: Date

10/08/2018

Date of study closure: Type

Actual

Date of study closure: Date

31/12/2020

Recruitment status

Complete

Date of completion

12/01/2018

IPD sharing statement plan

Yes

IPD sharing statement description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Additional data URL

https://clinicaltrials.gov/ct2/show/record/NCT02941926?recrs=d&rslt=Without&type=Intr&cond=Advanced+Breast+Cancer&titles=compleement&spons=novartis&phase=2&rank=1

Summary Results

Secondary Identifying Numbers

Full name of issuing authority	Secondary identifying number
Clinical Trials.Gov	NCT02941926

Sources of Monetary or Material Support

Name
Novartis Pharma Services Inc.

Secondary Sponsors

Name
NA

Contact for Public/Scientific Queries

Contact type	First name	Last name	Address	Country	Telephone	Email	Affiliation
Public	Fadi	Farhat	Saida	Lebanon	+961 3 753 155	drfadi.trials@gmail.com	Hammoud Hospital
Scientific	Hind	Khairallah	Beirut	Lebanon	+961 1 512002 Ext. 271	Hind.Khairallah@fattal.com.lb	Khalil Fattal et Fils s.a.l.
Public	Fadi	El Karak	Mansourieh	Lebanon	+961 3 061 621	felkarak@yahoo.com	Bellevue Medical Center
Public	Georges	Chahine	Beirut	Lebanon	+9613 647778	Chahine_georges@hotmail.com	Hotel Dieu De France

Centers/Hospitals Involved in the Study

Center/Hospital name	Name of principles investigator	Principles investigator speciality	Ethical approval
Hammoud Hospital University Medical Center	Dr Fadi Farhat	Hematology Oncology	Approved
Hotel Dieu De France	Dr Georges Chahine	Hematology Oncology	Approved
Bellevue Medical Center	Dr Fadi El Karak	Hematology Oncology	Approved

Ethics Review

Ethics approval obtained	Approval date	Contact name	Contact email	Contact phone
Hotel Dieu de France	02/05/2017	Georges Chahine	Chahine_georges@hotmail.com	009613 647778
Bellevue Medical Center	21/08/2017	Fadi El Karak	felkarak@yahoo.com	00961 3 061 621
Hammoud Hospital University Medical Center	02/05/2017	Fadi Farhat	drfadi.trials@gmail.com	00961 3 753 155

Countries of Recruitment

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

Health Conditions or Problems Studied

Condition	Code	Keyword
Advanced Breast Cancer	Breast, unspecified (C50.9)	Breast Cancer

Interventions

Intervention	Description	Keyword
> Hematology tests: WBC, ANC, lymphocyte, hemoglobin, platelets (as clinically indicated), Chemistry tests: Alkaline phosphatase, ALT (SGPT), AST (SGOT), calcium corrected for serum albumin, creatinine or creatinine clearance, potassium, sodium, magnesium,direct bilirubin, total bilirubin (as clinically indicated), ECG	Lab tests , ECG , Radiology assessment	Lab tests , Radiology , ECG

Primary Outcomes

Name	Time points	Measure
The number of participants with adverse events as a measure of safety and tolerability	PFS	Progression free survival

Key Secondary Outcomes

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

Trial Results

Summary results in Lebanon

Study results globally

Date of posting of results summaries

Date of first journal publication of results

Results URL link

Baseline characteristics

Participant flow

Adverse events

Outcome measures

URL to protocol files

Link(s) to publications related to the study

Changes History

Change	Date
added IB, SAE, SUSARS, PD as per annual process	15/12/2019

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Trial details