A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Status: Recruiting
Location: See all (139) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).

• Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.

• Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.

• Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.

• For participants with prior ET treatment \> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.

• The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.

• Participant has no contraindication to receive adjuvant ET in the study.

• Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:

‣ Anatomic Stage Group III, or

⁃ Anatomic Stage Group IIB, or

⁃ A subset of Anatomic Stage Group IIA.

• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.

• Participant has adequate bone marrow and organ function.

• ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:

‣ QTcF interval at Screening \< 450 msec (QT interval using Fridericia's correction).

⁃ Mean resting heart rate 50-99 beats per minute (determined from the ECG).

Locations
United States
Alaska
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Arkansas
CARTI Cancer Center
RECRUITING
Little Rock
California
Palo Alto Medical Foundation
RECRUITING
Mountain View
UC Irvine Medical Center
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Orange
Colorado
Rocky Mountain Cancer Centers
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Denver
Washington, D.c.
Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Holy Cross Health
RECRUITING
Fort Lauderdale
Ocala Research Institute, Inc
RECRUITING
Ocala
Georgia
Summit Cancer Care PC
RECRUITING
Savannah
Illinois
Affiliated Oncologists IL
RECRUITING
Chicago
Hope And Healing Care
RECRUITING
Hinsdale
Indiana
Investigative Clinical R of Indiana
RECRUITING
Indianapolis
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Cancer Center of Kansas
RECRUITING
Wichita
Louisiana
Willis-Knighton Cancer Center
RECRUITING
Shreveport
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Maryland Oncology Hematology P A
RECRUITING
Silver Spring
Minnesota
Minnesota Oncology Hematology P A
RECRUITING
Minneapolis
Missouri
WA Uni School Of Med
RECRUITING
St Louis
Mississippi
Jackson Oncology Associates
RECRUITING
Jackson
Montana
Intermountain Healthcare
RECRUITING
Billings
Nebraska
Nebraska Cancer Specialists
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Omaha
New Jersey
The Valley Hospital
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Ridgewood
Nevada
Renown Regional Medical Center
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Reno
New York
Clinical Research Alliance
RECRUITING
Lake Success
Mount Sinai School of Medicine
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New York
Oregon
Oncology Associates of Oregon PC
RECRUITING
Eugene
Northwest Cancer Specialists
RECRUITING
Portland
Oregon Oncology Specialists Salem
RECRUITING
Salem
Pennsylvania
Consultants In Med Onco And Hema
RECRUITING
Drexel Hill
Rhode Island
Rhode Island Hospital
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Providence
Tennessee
Sarah Cannon Research Institute
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Nashville
Texas
El Paso Texas Oncology
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El Paso
Texas Oncology P A Plano East
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Plano
Texas Oncology PA Tyler
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Tyler
Virginia
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Providence Regional Cancer System
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Lacey
Northwest Medical Specialties
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Tacoma
Other Locations
Australia
Novartis Investigative Site
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Clayton
Novartis Investigative Site
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East Melbourne
Novartis Investigative Site
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Gateshead
Novartis Investigative Site
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Tiwi
Canada
Novartis Investigative Site
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Halifax
Novartis Investigative Site
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Montreal
Novartis Investigative Site
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Montreal
Novartis Investigative Site
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Montreal
Novartis Investigative Site
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Ottawa
Novartis Investigative Site
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Québec
China
Novartis Investigative Site
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Changchun
Novartis Investigative Site
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Chengdu
Novartis Investigative Site
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Chengdu
Novartis Investigative Site
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Guangzhou
Novartis Investigative Site
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Hangzhou
Novartis Investigative Site
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Hangzhou
Novartis Investigative Site
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Jinan
Novartis Investigative Site
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Nanchang
Novartis Investigative Site
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Nanjing
Novartis Investigative Site
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Shanghai
Novartis Investigative Site
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Ürümqi
Novartis Investigative Site
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Zhengzhou
Germany
Novartis Investigative Site
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Augsburg
Novartis Investigative Site
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Augsburg
Novartis Investigative Site
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Bergisch Gladbach
Novartis Investigative Site
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Berlin
Novartis Investigative Site
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Berlin
Novartis Investigative Site
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Bielefeld
Novartis Investigative Site
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Böblingen
Novartis Investigative Site
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Bottrop
Novartis Investigative Site
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Dessau
Novartis Investigative Site
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Dresden
Novartis Investigative Site
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Düsseldorf
Novartis Investigative Site
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Erlangen
Novartis Investigative Site
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Essen
Novartis Investigative Site
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Essen
Novartis Investigative Site
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Freiburg Im Breisgau
Novartis Investigative Site
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Hamburg
Novartis Investigative Site
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Hildesheim
Novartis Investigative Site
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Kiel
Novartis Investigative Site
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Langen
Novartis Investigative Site
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Leipzig
Novartis Investigative Site
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Lübeck
Novartis Investigative Site
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Mainz
Novartis Investigative Site
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Mönchengladbach
Novartis Investigative Site
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München
Novartis Investigative Site
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Munich
Novartis Investigative Site
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Ravensburg
Novartis Investigative Site
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Regensburg
Novartis Investigative Site
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Velbert
Novartis Investigative Site
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Weiden
Hong Kong Special Administrative Region
Novartis Investigative Site
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Hong Kong
Novartis Investigative Site
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Kowloon
Novartis Investigative Site
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Pokfulam
Novartis Investigative Site
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Tuenmen
India
Novartis Investigative Site
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Ahmedabad
Novartis Investigative Site
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Chennai
Novartis Investigative Site
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Hyderabad
Novartis Investigative Site
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Mumbai
Novartis Investigative Site
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Nashik
Israel
Novartis Investigative Site
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Beersheba
Novartis Investigative Site
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Petah Tikva
Novartis Investigative Site
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Ramat Gan
Novartis Investigative Site
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Tel Aviv
Portugal
Novartis Investigative Site
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Porto
Novartis Investigative Site
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Porto
Novartis Investigative Site
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Porto
Republic of Korea
Novartis Investigative Site
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Bundang Gu
Novartis Investigative Site
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Gyeonggi-do
Novartis Investigative Site
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Incheon
Novartis Investigative Site
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Seongnam
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Novartis Investigative Site
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Seoul
Taiwan
Novartis Investigative Site
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Hualien City
Novartis Investigative Site
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Kaohsiung City
Novartis Investigative Site
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Tainan City
Novartis Investigative Site
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Taipei
Novartis Investigative Site
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Taipei
Turkey
Novartis Investigative Site
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Ankara
Novartis Investigative Site
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Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
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Ankara
Novartis Investigative Site
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Antalya
Novartis Investigative Site
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Denizli
Novartis Investigative Site
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Diyarbakır
Novartis Investigative Site
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Istanbul
Novartis Investigative Site
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Istanbul
Novartis Investigative Site
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Istanbul
Novartis Investigative Site
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Istanbul
Novartis Investigative Site
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Izmir
Novartis Investigative Site
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Kecioren Ankara
Novartis Investigative Site
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Konya
Novartis Investigative Site
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Sakarya
Novartis Investigative Site
RECRUITING
Samsun
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2030-09-20
Participants
Target number of participants: 1400
Treatments
Experimental: Ribociclib + endocrine therapy
Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of:~* For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously.~* For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin subcutaneously (at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used) or leuprolide subcutaneously (at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used)
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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