MEtronomic TrEatment Option in Advanced bReast cAncer

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT02954055
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Arm A
  • Cyclophosphamide — DRUG
    Arm B
  • Capecitabine — DRUG
    Arm B
  • Vinorelbine — DRUG
    Arm B

Study Details

This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy.

Key Dates

Start date
Sep 13, 2017
Status verified
Feb 2024
Primary completion
Nov 17, 2021
Completion
Nov 23, 2022

Study Design

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

Arms

  • Active Comparator: Arm A
    Paclitaxel 90 mg/m2 days 1, 8, 15 q4w. Patients will continue to receive assigned treatment until progression or lack of tolerability.
  • Experimental: Arm B
    Metronomic VEX: Cyclophosphamide 50 mg orally once daily continuously, Capecitabine 500 mg, orally 3 times a day (1500 mg/day) continuously, Vinorelbine 40 mg orally days 1, 3, 5 each week continuously. Patients will continue to receive assigned treatment until progression or lack of tolerability.

Primary Outcome Measure

Time to Treatment Failure (TTF) Compared Between Treatment Groups. [ Time Frame: Assessed at the start of every 4-week (28-day) treatment cycle from randomization to the end of treatment date or discontinuation; median follow-up was 29 months, with a minimum of 0.2 months and maximum of 48.5 months. ]

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