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

Phase 2

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

• Registration Number: CTRI/2019/09/021458
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 β-hCG) within 14 days prior to randomization.

ï?· Women of CBP must be willing to use highly effective methods of contraception.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified