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Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

NCT03048942 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-11-13

No results posted yet for this study

Summary

90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

Conditions

  • HER2 Negative Metastatic Breast Cancer

Interventions

DRUG

Cabazitaxel

3 weekly cyctotoxic chemotherapy

DRUG

Paclitaxel

Weekly cyctotoxic chemotherapy

Sponsors & Collaborators

  • University Hospitals Bristol and Weston NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amit K Bahl · University Hospitals Bristol and Weston NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03048942 on ClinicalTrials.gov