A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT02730091
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Letrozole — DRUG
    Letrozole 2.5 mg daily
  • Anastrozole — DRUG
    anastrozole 1 mg daily
  • Vinorelbine — DRUG
    50 mg three times a week (Monday Wednesday and Friday)

Study Details

This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer without resistance to Aromatase Inhibitors (AI).

Key Dates

Start date
Feb 24, 2016
Status verified
Jan 2021
Primary completion
Mar 23, 2020
Completion
Mar 23, 2020

Study Design

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

Arms

  • Active Comparator: Letrozole or anastrozole
    Letrozole 2,5 mg once a day or anastrozole 1 mg once a day until disease progression, unacceptable toxicity, patient's refusal, consent withdrawal, death, or discontinuation from the study treatment for any other reason.
  • Experimental: Vinorelbine + Anastrozole or letrozole
    Oral vinorelbine 50 mg (1 soft capsule of 30 mg and 1 soft capsule of 20 mg) three times a week every ( Monday, Wednesday and Friday) before lunch and letrozole 2,5 mg once a day or anastrozole 1 mg once a day until disease progression, unacceptable toxicity, patient's refusal, consent withdrawal, death, or discontinuation from the study treatment for any other reason.

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: up to 5 years ]

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