Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT02802748
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oral Vinorelbine — DRUG
    Metronomic Schedule of Vinorelbine administered orally in a schedule monday-wednesday-friday, tuesday-thursday-saturday, etc
  • Letrozole — DRUG
    Letrozole will be administered orally at 2.5 mg QD for 3 weeks.

Study Details

VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.

Key Dates

Start date
Jul 31, 2016
Status verified
Sep 2018
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Metronomic Vinorelbine + Letrozole
    * Oral Vinorelbine: 50 mg (30 mg + 20 mg) three times a week, for 3 weeks * Letrozole: 2.5mg daily, for 3 weeks
  • Active Comparator: Letrozole alone
    Letrozole: 2.5mg daily, for 3 weeks
  • Active Comparator: Metronomic Vinorelbine alone
    Oral Vinorelbine: 50 mg (30 mg + 20 mg) three times a week, for 3 weeks

Primary Outcome Measure

Changes in the expression of the PAM50 proliferation signature upon treatment in patients defined as Luminal by PAM50 [ Time Frame: At the time of surgery ]

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