Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-28 @ 3:04 AM
Study NCT ID:
NCT03701334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589651', 'term': 'ribociclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5101}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05038631', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive Disease-Free Survival (iDFS)', 'timeFrame': 'Up to approximately 91 months', 'description': 'iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as time from the date of randomization to the date of the first event of local invasive breast recurrence, 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).'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': 'Up to approximately 91 months', 'description': 'RFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials). RFS is defined as the time from date of randomization to date of first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, or death (any cause).'}, {'measure': 'Distant disease-free survival (DDFS)', 'timeFrame': 'Up to approximately 91 months', 'description': 'DDFS using STEEP criteria. DDFS is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 91 months', 'description': 'OS is defined as the time from date of randomization to date of death due to any cause.'}, {'measure': 'Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30', 'timeFrame': 'Up to approximately 91 months', 'description': 'The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.'}, {'measure': 'Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30', 'timeFrame': 'Up to approximately 91 months', 'description': 'The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.'}, {'measure': 'PK parameters: Ctrough and other applicable parameters for ribociclib', 'timeFrame': 'Cycle 1 Day 15', 'description': 'Pharmacokinetics of ribociclib: Ctrough and other applicable parameters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early breast cancer (EBC)', 'HR+/HER2-', 'adjuvant', 'LEE011', 'ribociclib', 'CDK4/6 inhibitor'], 'conditions': ['Early Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40996773', 'type': 'DERIVED', 'citation': 'Fasching PA, Stroyakovskiy D, Yardley DA, Huang CS, Crown J, Bardia A, Chia S, Im SA, Martin M, Xu B, Loi S, Barrios C, Untch M, Moroose R, Visco F, Hortobagyi GN, Slamon DJ, Fresco R, Zarate JP, Li Z, Waters S, Hurvitz SA. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1364-1372. doi: 10.1001/jamaoncol.2025.3700.'}, {'pmid': '38507751', 'type': 'DERIVED', 'citation': 'Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488.'}, {'pmid': '37275963', 'type': 'DERIVED', 'citation': 'Slamon DJ, Fasching PA, Hurvitz S, Chia S, Crown J, Martin M, Barrios CH, Bardia A, Im SA, Yardley DA, Untch M, Huang CS, Stroyakovskiy D, Xu B, Moroose RL, Loi S, Visco F, Bee-Munteanu V, Afenjar K, Fresco R, Taran T, Chakravartty A, Zarate JP, Lteif A, Hortobagyi GN. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023 May 29;15:17588359231178125. doi: 10.1177/17588359231178125. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)', 'detailedDescription': 'The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.\n\nApproximately 5,000 patients will be randomized (using an Interactive Response Technology system \\[IRT\\]) into two treatment arms in a 1:1 ratio.\n\nThe trial will include screening, treatment, and follow up phases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years-old at the time of PICF signature\n* Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.\n* Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.\n* Patient has breast cancer that is positive for ER and/or PgR\n* Patient has HER2-negative breast cancer\n* Patient has available archival tumor tissue from the surgical specimen\n* Patient 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 II or III\n* If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines\n* If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines\n* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years\n\nExclusion Criteria:\n\n* Patient has received any CDK4/6 inhibitor\n* Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.\n* Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.\n* Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET\n* Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.\n* Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET\n* Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization\n* Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies\n* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization\n* Patient has known HIV infection, Hepatitis B or C infection\n* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality\n* Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\n* is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment\n* Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments\n* Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator\'s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol\n* Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial'}, 'identificationModule': {'nctId': 'NCT03701334', 'acronym': 'NATALEE', 'briefTitle': 'A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)', 'orgStudyIdInfo': {'id': 'CLEE011O12301C'}, 'secondaryIdInfos': [{'id': '2023-510357-42-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ribociclib + Endocrine Therapy', 'description': 'Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously', 'interventionNames': ['Drug: Ribociclib', 'Other: Endocrine Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endocrine Therapy', 'description': 'Participants will receive endocrine therapy only once daily continuously', 'interventionNames': ['Other: Endocrine Therapy']}], 'interventions': [{'name': 'Ribociclib', 'type': 'DRUG', 'description': 'Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle', 'armGroupLabels': ['Ribociclib + Endocrine Therapy']}, {'name': 'Endocrine Therapy', 'type': 'OTHER', 'description': 'ET will be administered according to the local clinical guidelines and current local prescribing information', 'armGroupLabels': ['Endocrine Therapy', 'Ribociclib + Endocrine Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham-Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cancer Treatment Centers of America', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'St Bernards Medical Center', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Beverly Hills', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Burbank', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Encino Research Center', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Medical Group', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology Oncology', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southern CA Oncology Rsrch Alliance', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': 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