Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line

Sponsor
iOMEDICO AG
Study ID
NCT03462251
Phase
PHASE3
Status
Completed

Conditions

  • Breast Cancer
  • HER 2 Negative Breast Cancer
  • Hormone Receptor Positive Tumor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis. Half of the patients will receive a combination of ribociclib and AI/fulvestrant while the other half will receive capecitabine + bevacizumab or paclitaxel +/- bevacizumab.

Key Dates

Start date
May 24, 2018
Status verified
Jan 2023
Primary completion
Nov 30, 2021
Completion
Nov 30, 2022

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Combination of ribociclib and aromatase inhibitor or fulvestrant
  • Active Comparator: Arm B
    Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab

Primary Outcome Measure

Efficacy in terms of PFS [ Time Frame: Up to approximately 15 months. ]

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