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

NCT03462251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-01-19

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

Ribociclib and aromatase inhibitor or fulvestrant

Combination of ribociclib and aromatase inhibitor or fulvestrant

COMBINATION_PRODUCT

Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab

Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab

Sponsors & Collaborators

Principal Investigators

  • Thomas Decker, Prof. · Gemeinschaftspraxis für Hämatologie und Onkologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2021-11-30
Completion
2022-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462251 on ClinicalTrials.gov