Clinical Trials Logo
  1. Home
  2. Early Breast Cancer
  3. NCT03701334

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

Early Breast Cancer Clinical Trial

Official title:
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)

Clinical Trial Summary

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)

Clinical Trial 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. The trial will include screening, treatment, and follow up phases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03701334
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 7, 2018
Completion date May 29, 2026
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04538833 - GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel Phase 2
Completed NCT04436744 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) Phase 2
Completed NCT02187744 - A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04) Phase 3
Terminated NCT01155063 - Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients N/A
Recruiting NCT03949634 - Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin（PLD) Phase 3
Active, not recruiting NCT05730647 - Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
Terminated NCT01919229 - A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) Phase 2
Active, not recruiting NCT04293393 - Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients Phase 2
Completed NCT00713141 - Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer N/A
Recruiting NCT06341894 - Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer Phase 2
Not yet recruiting NCT06404736 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer Phase 2
Not yet recruiting NCT06404463 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer Phase 2
Not yet recruiting NCT06435104 - Aromatherapy in the Treatment of Early Breast Cancer Phase 2
Recruiting NCT03520894 - Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer N/A
Completed NCT03786198 - Activity Program During Aromatase Inhibitor Therapy N/A
Completed NCT01613352 - Feasibility of Ambulatory Surgery for Early Breast Cancer N/A
Completed NCT02738970 - A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC) Phase 1
Recruiting NCT01792726 - A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. N/A
Completed NCT00323479 - Arthralgia During Anastrozole Therapy for Breast Cancer Phase 4
Completed NCT03493854 - A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer Phase 3