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Roll-over Study to Allow Continued Access to Ribociclib

Primary Purpose

Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ribociclib
Letrozole
Anastrozole
Goserelin
Tamoxifen
Fulvestrant
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Roll-over Protocol, Ribociclib, HR-positive, HER2-negative, Breast Cancer, Ribociclib in combination with other drugs, LEE011

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key inclusion Criteria:

  1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
  2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
  3. Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

  1. Permanent discontinuation of ribociclib in the parent study
  2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Sites / Locations

  • Ironwood Cancer and Research CentersRecruiting
  • Highlands Oncology GroupRecruiting
  • Beverly Hills Cancer CenterRecruiting
  • Poudre Valley HospitalRecruiting
  • Mid Florida Hematology and Onc CtrRecruiting
  • Summit Cancer CareRecruiting
  • John D Archbold Memorial HospitalRecruiting
  • Joliet Oncology-Hematology AssociatesRecruiting
  • Indian Univ Health Goshen Center forCancerRecruiting
  • Northern Light Mercy HospitalRecruiting
  • Englewood HealthRecruiting
  • The Valley Hospital / Luckow PavillionRecruiting
  • Eastchester Center for Cancer CareRecruiting
  • University Hospitals of Cleveland Seidman Cancer CenterRecruiting
  • Oklahoma Cancer Specialists and Research InstituteRecruiting
  • Millennium Research Clin DevelopRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ribociclib

Arm Description

All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.

Outcomes

Primary Outcome Measures

Percentage of participants with treatment-emergent adverse events (AES)
The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment

Secondary Outcome Measures

Clinical benefit rate
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits

Full Information

First Posted
December 3, 2021
Last Updated
October 2, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05161195
Brief Title
Roll-over Study to Allow Continued Access to Ribociclib
Official Title
A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
January 19, 2028 (Anticipated)
Study Completion Date
February 16, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.
Detailed Description
The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Roll-over Protocol, Ribociclib, HR-positive, HER2-negative, Breast Cancer, Ribociclib in combination with other drugs, LEE011

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribociclib
Arm Type
Other
Arm Description
All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.
Intervention Type
Drug
Intervention Name(s)
Ribociclib
Intervention Description
Participants continue ribociclib as was administered in their parent study
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Description
Participants continue ribociclib in combination with goserelin as was administered in their parent study
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (AES)
Description
The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment
Time Frame
From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years
Secondary Outcome Measure Information:
Title
Clinical benefit rate
Description
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion Criteria: Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s) Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study Currently has evidence of clinical benefit as determined by the Investigator Key exclusion Criteria: Permanent discontinuation of ribociclib in the parent study Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed Other protocol-defined inclusion/exclusion criteria may apply at the end
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla Callendar
Phone
480-855-2225
Email
Priscilla.callender@ironwoodcrc.com
First Name & Middle Initial & Last Name & Degree
Mikhail I Shtivelband
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Torres
Phone
479-587-1700
Email
atorres@hogonc.com
First Name & Middle Initial & Last Name & Degree
J Thaddeus Beck
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noel Vargas
Phone
310-432-8900
Email
nvargas@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Linnea Chap
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Swim
Phone
+1 970 297 6155
Email
ashley.swim@uchealth.org
First Name & Middle Initial & Last Name & Degree
Chelsea Dianne Gawryletz
Facility Name
Mid Florida Hematology and Onc Ctr
City
Orange
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Edwards
Phone
386-774-1223
Email
dedwards@aorcorp.com
First Name & Middle Initial & Last Name & Degree
Santosh Nair
Facility Name
Summit Cancer Care
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Wiggins
Phone
912-651-5771
Email
rwiggins@summitcancercare.com
First Name & Middle Initial & Last Name & Degree
Alison Spellman
Facility Name
John D Archbold Memorial Hospital
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendall Fowler
Phone
229-228-2800
Email
kbfowler@archbold.org
First Name & Middle Initial & Last Name & Degree
Josh D Simmons
Facility Name
Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonya Finger
Phone
815-730-3098
Email
tonya.finger@dulyhealthandcare.com
First Name & Middle Initial & Last Name & Degree
Nafisa Burhani
Facility Name
Indian Univ Health Goshen Center forCancer
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Messick
Phone
574-535-2888
Email
jmessick@goshenhealth.com
First Name & Middle Initial & Last Name & Degree
Ebenezer A Kio
Facility Name
Northern Light Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
207-553-6868
First Name & Middle Initial & Last Name & Degree
Anna Niegowska
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Ades
Phone
201-568-5250
Email
Audrey.Ades@EHMChealth.org
First Name & Middle Initial & Last Name & Degree
Jill Morrison
Facility Name
The Valley Hospital / Luckow Pavillion
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheena Patel
Phone
201-634-5792
Email
spatel12@valleyhealth.com
First Name & Middle Initial & Last Name & Degree
Eleonora Teplinsky
Facility Name
Eastchester Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujey Diaz
Phone
718-732-4000
Email
sudiaz@nycancer.com
First Name & Middle Initial & Last Name & Degree
Fabio Volterra
Facility Name
University Hospitals of Cleveland Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Moore
Email
Crystal.Moore@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Cynthia Owusu
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Niceley
Phone
918-292-8085
Email
Andrea.Niceley@ocsri.org
First Name & Middle Initial & Last Name & Degree
Kevin Weibel
Facility Name
Millennium Research Clin Develop
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
832-561-1840
First Name & Middle Initial & Last Name & Degree
Isaac Levy
Facility Name
Novartis Investigative Site
City
Ijuí
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317 000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
03102
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090 000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
ZIP/Postal Code
01255-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Jose
ZIP/Postal Code
95008
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heraklion Crete
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shatin New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bunkyo ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bunkyo ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Koto ku
State/Province
Tokyo
ZIP/Postal Code
135 8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Chouf
State/Province
LBN
ZIP/Postal Code
1503201002
Country
Lebanon
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Monterrey Nuevo Leon
State/Province
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80 952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sant Joan Despi
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10041
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
103616
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Diyarbakir
ZIP/Postal Code
21000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kecioren Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Roll-over Study to Allow Continued Access to Ribociclib

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