A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021458

Enrollment

350

Registered

2019-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: â?¢Drug: Ribociclib â?¢Drug: Letrozole or Anastrozole â?¢Drug: Goserelin: â?¢Drug: Ribociclib Ribociclib will be supplied as 200 mg tablets as individual patient supply packaged bott

Eligibility

Inclusion criteria

Inclusion criteria: Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy. Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation). Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for Î²-hCG) within 14 days prior to randomization. ï?· Women of CBP must be willing to use highly effective methods of contraception.

Exclusion criteria

Exclusion criteria: Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigatorâ??s judgment. Patient is concurrently using other anti-cancer therapy. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities. Patient has a concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ.

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) [ ORR is based on local tumor assessments (RECIST version 1.1) for all patients that have been treated for at least 6 months or have discontinued the study treatment.Timepoint: Overall Response Rate (ORR) [ ORR is based on local tumor assessments (RECIST version 1.1) for all patients that have been treated for at least 6 months or have discontinued the study treatment.	—

Secondary

Measure	Time frame
â?¢Î? QTcF at Cycle 1 Day 15 (at 2h post-dose) (Key Secondary Endpoint) â?¢Progression-free survival (PFS) â?¢Clinical benefit rate (CBR)Timepoint: Cycle 1 Day 15 (2 hours post dose) Approximately 36 months Approximately 36 months	—

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hungary, India, Jordan, Lithuania, Peru, Portugal, Russian Federation, Saudi Arabia, South Africa, Sweden, Thailand, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Pvt Ltd

murugananthan.k@novartis.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026