NCT02730091

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

A Randomized 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Letrozole and Anastrozole are AI generally used as the first line of therapy for women with HR+ breast cancer. Furthermore, present hormonal treatments of advanced breast cancer (ABC) or Metastatic breast cancer (MBC) are sub-optimal, as only approximately one half of patients with oestrogen and/or progesterone receptor positive tumours will respond to therapy. For this patient population, chemotherapy is a valid option, especially after failure or intolerance to hormone therapy. Both combination and sequential single-agent chemotherapy are reasonable options. Based on the available data, sequential monotherapy is recommended as the preferred choice for MBC. Preferred first-line chemotherapy single agents are anthracyclines, taxanes, capecitabine, gemcitabine and vinorelbine. The development of oral chemotherapy formulations offer numerous benefits to patients, oncologists, oncology nurses, pharmacists and healthcare providers Metronomic therapy (MT) refers to repetitive, low doses of chemotherapy drugs. MT exerts an effect not only on tumor cells, but also on their microenvironment. In particular, the low-dose schedule compromises the repairing process of endothelial cells, leading to an anti-angiogenic effect. A systematic review of the results of phase I, II and III studies suggests that MT is a treatment option for breast cancer patients, has a low toxicity profile, efficacy in most patients and has potentially significant cost-effective advantages for public health.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2016-02-24
• Primary completion: 2020-03-23
• Completion: 2020-03-23
• First posted: 2016-04-06
• Last updated: 2021-02-01

Locations

1 site across 1 country: France