Early Breast CancerPhase 3Adjuvant WIDERNCT05827081
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
A Phase 3 study testing Ribociclib, Letrozole and Ansastrozole in people with Early Breast Cancer, run by Novartis Pharmaceuticals at 214 sites in 16 countries.
Trial 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+)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Ribociclib, Letrozole and Ansastrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,464 participants
- Where
- 214 sitesin 16 countries
- Study dates
- 28 Feb 2024to 20 Sep 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
- Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
214 sites in 16 countries.
214 sites in 16 countries
United States79 sites
Presbyterian Medical Group
Albuquerque, New Mexico, 87110
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Mercy Medical Center
Baltimore, Maryland, 21202
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Intermountain Healthcare
Billings, Montana, 59102
Central Alabama Research
Birmingham, Alabama, 35209
Boston Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
MD Anderson Cancer Center At Cooper
Camden, New Jersey, 08103
Onco Inst of Hope and Innovation
Cerritos, California, 90703
Affiliated Oncologists IL
Chicago, Illinois, 60415
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania, 19026
City of Hope National Medical
Duarte, California, 91010
Duke Cancer Network
Durham, North Carolina, 27710
El Paso Texas Oncology
El Paso, Texas, 79902
Oncology Associates of Oregon PC
Eugene, Oregon, 97401-8122
Sanford Research USD Fargo
Fargo, North Dakota, 58122
Summit Health
Florham Park, New Jersey, 07932
Holy Cross Health
Fort Lauderdale, Florida, 33308
Providence Medical Foundation
Fullerton, California, 92835
Western Reg MC-COH Phoenix
Goodyear, Arizona, 85338
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Bon Secours St Francis Cancer Center
Greenville, South Carolina, 29607
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania, 17109
Hialeah Hospital
Hialeah, Florida, 33013
Hope And Healing Care
Hinsdale, Illinois, 60521
Memorial Cancer Institute
Hollywood, Florida, 33021
Kelsey Seybold Clinic
Houston, Texas, 77025
University of Texas
Houston, Texas, 77030-4099
Investigative Clinical R of Indiana
Indianapolis, Indiana, 46260
Jackson Oncology Associates
Jackson, Mississippi, 39202
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Jupiter Medical Center
Jupiter, Florida, 33458
HCA Midwest Division
Kansas City, Missouri, 64132
Kadlec Clinic Hematology and Onco
Kennewick, Washington, 99336
Providence Regional Cancer System
Lacey, Washington, 98503
Optum Health
Lake Success, New York, 11042
CARTI Cancer Center
Little Rock, Arkansas, 72205
Los Angeles Cancer Network Good Samaritan
Los Angeles, California, 90017
Bon Secours Virginia Health System
Midlothian, Virginia, 23114
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, 55404
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota, 55407
El Camino Hospital
Mountain View, California, 94040
Palo Alto Medical Foundation
Mountain View, California, 94040
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Mount Sinai School of Medicine
New York, New York, 10029
Virginia Oncology Associates
Norfolk, Virginia, 23502
Ocala Research Institute Inc
Ocala, Florida, 34474
Nebraska Cancer Specialists
Omaha, Nebraska, 68154
UC Irvine Medical Center
Orange, California, 92868
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Texas Oncology P A Plano East
Plano, Texas, 75075
Northwest Cancer Specialists
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
Renown Regional Medical Center
Reno, Nevada, 89502
Cancer Care Specialists
Reno, Nevada, 89511
Valley Medical Center Research
Renton, Washington, 98055
The Valley Hospital
Ridgewood, New Jersey, 07450
Sutter Inst Medical Research
Sacramento, California, 95816-5199
School Of Medicine
Sacramento, California, 95817
Oregon Oncology Specialists Salem
Salem, Oregon, 97301
Sharp Rees Stealy Medical Group Inc
San Diego, California, 92101
Summit Cancer Care PC
Savannah, Georgia, 31405
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104
WA Uni School Of Med
St Louis, Missouri, 63110
Northwest Medical Specialties
Tacoma, Washington, 98405
Texas Oncology PA Tyler
Tyler, Texas, 75702
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Iowa Health Care
Waukee, Iowa, 50263
University of Kansas Cancer Center
Westwood, Kansas, 66205
Cancer Center of Kansas
Wichita, Kansas, 67214-3728
Midwestern Reg MC COH Chicago
Zion, Illinois, 60099
China24 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100044
Novartis Investigative Site
Beijing, 100039
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chengdu, Sichuan, 610072
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310022
Novartis Investigative Site
Harbin, Heilongjiang, 150081
Novartis Investigative Site
Jinan, Shandong, 250021
Novartis Investigative Site
Jinan, Shandong, 250117
Novartis Investigative Site
Jining, Shandong, 272000
Novartis Investigative Site
Nanchang, Jiangxi, 330009
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Qingdao, 266000
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Shijiazhuang, 050035
Novartis Investigative Site
Tianjin, 300480
Novartis Investigative Site
Ürümqi, Xinjiang, 830000
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Zhengzhou, Henan, 450003
Novartis Investigative Site
Zhengzhou, Henan, 450008
Germany21 sites
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Bergisch Gladbach, North Rhine-Westphalia, 51465
Novartis Investigative Site
Berlin, 10967
Novartis Investigative Site
Bottrop, 46236
Novartis Investigative Site
Dessau, 06847
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45136
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Langen, Hesse, 63225
Novartis Investigative Site
Leipzig, 04277
Novartis Investigative Site
Mönchengladbach, North Rhine-Westphalia, 41061
Novartis Investigative Site
München, 80637
Novartis Investigative Site
Munich, Bavaria, 81377
Novartis Investigative Site
Ravensburg, 88214
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Velbert, North Rhine-Westphalia, 42551
Novartis Investigative Site
Weiden in Der Oberpfalz, Bavaria, 92637
Turkey (Türkiye)20 sites
Novartis Investigative Site
Adana, Yuregir, 01230
Novartis Investigative Site
Ankara, Bilkent Cankaya, 06800
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
Novartis Investigative Site
Ankara, Yenimahalle, 06200
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Ankara, 06520
Novartis Investigative Site
Antalya, Konyaalti, 07070
Novartis Investigative Site
Denizli, Kinikli, 20070
Novartis Investigative Site
Diyarbakır, Sur, 21280
Novartis Investigative Site
Istanbul, Fatih, 34098
Novartis Investigative Site
Istanbul, Kadikoy, 34722
Novartis Investigative Site
Istanbul, Sariyer, 34457
Novartis Investigative Site
Istanbul, Uskudar, 34662
Novartis Investigative Site
Istanbul, 34147
Novartis Investigative Site
Izmir, Karsiyaka, 35575
Novartis Investigative Site
Izmir, 35100
Novartis Investigative Site
Kecioren Ankara, 06010
Novartis Investigative Site
Konya, 42080
Novartis Investigative Site
Sakarya, Adapazari, 54290
Novartis Investigative Site
Samsun, 55200
South Korea12 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
Novartis Investigative Site
Incheon, 21565
Novartis Investigative Site
Seongnam Gyeonggi, 13496
Novartis Investigative Site
Seoul, Korea, 02841
Novartis Investigative Site
Seoul, Yangcheon Gu, 07985
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06273
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Seoul, 06591
Canada11 sites
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
Montreal, Quebec, H2X 0A9
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
Novartis Investigative Site
Oakville, Ontario, L6M 1M1
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1S 4L8
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 4H4
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5T 3L9
Novartis Investigative Site
Victoria, British Columbia, V8R 6V5
Brazil10 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30220-140
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90470-340
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-032
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
Rio de Janeiro, 22281-100
Novartis Investigative Site
Rio de Janeiro, 22775-001
Novartis Investigative Site
Salvador, Estado de Bahia, 40170-110
Novartis Investigative Site
São Paulo, São Paulo, 04502-001
Novartis Investigative Site
São Paulo, São Paulo, 05652-000
Novartis Investigative Site
São Paulo, 01323-000
India9 sites
Novartis Investigative Site
Ahmedabad, 380054
Novartis Investigative Site
Bangalore, Karnataka, 560017
Novartis Investigative Site
Bhubaneswar, Odisha, 751007
Novartis Investigative Site
Chennai, Tamil Nadu, 600035
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500034
Novartis Investigative Site
Kolkata, West Bengal, 700054
Novartis Investigative Site
Mumbai, Maharashtra, 400012
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Novartis Investigative Site
Pune, Maharasthra, 411028
Portugal6 sites
Novartis Investigative Site
Coimbra, 3000-075
Novartis Investigative Site
Lisbon, 1400-038
Novartis Investigative Site
Lisbon, 1649-035
Novartis Investigative Site
Porto, 4100-180
Novartis Investigative Site
Porto, 4200-072
Novartis Investigative Site
Porto, 4200-319
Taiwan5 sites
Novartis Investigative Site
Hualien City, 970
Novartis Investigative Site
Kaohsiung City, 80756
Novartis Investigative Site
Tainan, 71004
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11490
Australia4 sites
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Gateshead, New South Wales, 2290
Novartis Investigative Site
Tiwi, Northern Territory, 0810
Israel4 sites
Novartis Investigative Site
Beersheba, 8457108
Novartis Investigative Site
Petah Tikva, 4941492
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
Argentina3 sites
Novartis Investigative Site
Caba, Buenos Aires, C1426ANZ
Novartis Investigative Site
Córdoba, X5004BAL
Novartis Investigative Site
La Plata, Buenos Aires, B1902CMV
Hong Kong3 sites
Novartis Investigative Site
Hong Kong, 999077
Novartis Investigative Site
Kowloon, 999077
Novartis Investigative Site
Tuenmen, 999077
Mexico2 sites
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Novartis Investigative Site
Tlalpan, Mexico City, 14080
About this study
Official title: 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)
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).
Read the detailed description
The study consists of Screening, Treatment, and Follow-up periods.
- Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment.
- Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study [EOS]), whichever occurs first.
- Conditions
- Early Breast Cancer
- Being tested
- Ribociclib, Letrozole, Ansastrozole, Goserelin, Leuprolide
- Keywords
- Hormone receptor positive (HR+), Human epidermal growth factor receptor-2 negative (HER2-), Early breast cancer (EBC), premenopausal, postmenopausal, male breast cancer, ribociclib, LEE011, Endocrine therapy (ET)
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
Also called LEE011
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
LetrozoleDrug
Letrozole 2.5 mg orally once daily continuously
AnsastrozoleDrug
Anastrozole 1 mg orally once daily continuously.
GoserelinDrug
Goserelin administered 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
LeuprolideDrug
Leuprolide administered 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
ExemestaneDrug
Exemestane 25 mg once daily continuously
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib + endocrine therapy | Experimental | 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) Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Ansastrozole; Drug: Goserelin; Drug: Leuprolide; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator.
The iBCFS rate at 3 years will be assessed.
Measured: At 3 years
Secondary outcomes (13)
Incidence and severity of adverse events (AEs) using CTCAE v4.03
To evaluate Safety of ribociclib + ET
Measured: Up to approximately 6 years
Invasive Disease-Free Survival (iDFS)
iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Measured: Up to approximately 6 years
Distant Disease-Free Survival (DDFS)
Distant Disease-Free Survival (DDFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site, death (any cause), or second primary non-breast invasive cancer (excluding in situ/non-invasive cancers and basal and squamous cell carcinomas of the skin).
DDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Measured: Up to approximately 6 years
Distant Relapse-Free Survival (DRFS)
Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator.
Measured: Up to approximately 6 years
Recurrence-Free Interval (RFI)
RFI is defined as the time from date of first dose to date of first event of invasive recurrence in the ipsilateral breast or locoregionally, at a distant site, or death from breast cancer. RFI will be assessed using STEEP 2.0 as per investigator assessment.
Measured: Up to approximately 6 years
Relative dose intensity (RDI) of ribociclib
RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.
Measured: Up to 3 years
Overall Survival (OS)
OS is defined as time from the start of study treatment to date of death due to any cause.
Measured: Up to approximately 6 years
Time To Discontinuation (TTD) of ribociclib
TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.
Measured: Up to 3 years
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS.
Measured: Up to approximately 6 years
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.
Measured: Up to approximately 6 years
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Measured: Up to approximately 6 years
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D-5L health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Up to approximately 6 years
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
WPAI-GH measures the impact of health problems on the participant's productivity, in paid or unpaid activities, in the last 7 days. It is 6-item scale measuring absenteeism, presenteeism, and impairments in unpaid activity.
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start28 Feb 2024
- Primary completion7 Sep 2029 (estimated)
- Study completion20 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827081
- Sponsor's protocol ID
- CLEE011O12001
- Other IDs
- 2022-503001-38-00
- Acronym
- Adjuvant WIDER
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available