NCT03701334

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,101 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).

Detailed description

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. Approximately 5,000 patients will be randomized (using an Interactive Response Technology system \[IRT\]) into two treatment arms in a 1:1 ratio to: • Investigational arm: \~ Ribociclib 400 mg by mouth once daily on days 1 to 21 of a 28-day cycle, for 36 months since randomization (approximately 39 cycles). And \~ ET consisting of: * For postmenopausal women: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously. * For premenopausal women and men: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously, combined with goserelin 3.6 mg subcutaneously once every 4 weeks. Duration of ET in the trial will be 60 months from the randomization date. • Control arm: \~ ET: Same as in the Investigational arm. In both arms, ET will be administered according to the local clinical guidelines and current local prescribing information. Subsequent ET (or any other anti-cancer treatment) given after the protocol-required 60 months of ET (or after premature discontinuation of ET in the trial) will be administered according to the Investigator's clinical judgment and is not considered a trial treatment. Randomization will be stratified by the following factors: * Menopausal status: premenopausal women and men vs. postmenopausal women * AJCC 8th edition Anatomic Stage Group: Anatomic Stage Group II vs. Anatomic Stage Group III * Prior neoadjuvant/adjuvant chemotherapy: yes vs. no * Geographical region: North America/Western Europe/Oceania vs. rest of the world Enrollment of patients with Anatomic Stage Group II is capped at approximately 2,000 patients. The trial will include screening, treatment, and follow up phases. The trial includes an exploratory component that requires collection of tumor and blood samples (except for patients enrolled in China).

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle
OTHER	Endocrine Therapy (ET)	Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information

Timeline

• Start date: 2018-12-07
• Primary completion: 2030-05-29
• Completion: 2030-05-29
• First posted: 2018-10-10
• Last updated: 2026-04-01

Locations

387 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study