Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

NCT03887130 | Completed Phase 2 Results

• 1 other identifier: PM0259CA223B0
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable disease: no partial response or progression of the disease

  From Baseline to disease progression or death, up to 6 years

Study Arms (3)

Vinorelbine-Capecitabine (arm A)

EXPERIMENTAL

oral vinorelbine (OV) with capecitabine (CAP)

Drug: oral vinorelbine; Drug: Capecitabine

Gemcitabine-Paclitaxel (arm B)

ACTIVE COMPARATOR

gemcitabine (GEM) in combination with paclitaxel (PAC)

Drug: Gemcitabine 1250 mg/m²; Drug: Paclitaxel

Gemcitabine-Docetaxel (arm C)

ACTIVE COMPARATOR

gemcitabine (GEM) in combination with docetaxel (DOC)

Drug: Gemcitabine 1000 mg/m²; Drug: Docetaxel

Interventions

oral vinorelbine DRUG

Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles

Vinorelbine-Capecitabine (arm A)

Capecitabine DRUG

Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14

Vinorelbine-Capecitabine (arm A)

Gemcitabine 1250 mg/m² DRUG

Gemcitabine 1250 mg/m² on day 1 \& day 8

Gemcitabine-Paclitaxel (arm B)

Gemcitabine 1000 mg/m² DRUG

Gemcitabine: 1000 mg/m² on day 1 \& 8

Gemcitabine-Docetaxel (arm C)

Paclitaxel DRUG

Paclitaxel 175 mg/m² on day 1

Gemcitabine-Paclitaxel (arm B)

Docetaxel DRUG

Docetaxel 75 mg/m² on day 1

Gemcitabine-Docetaxel (arm C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the breast;
• Documented metastatic disease previously untreated by chemotherapy;
• HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
• Karnofsky Performance Status 70%.

You may not qualify if:

• Local relapse alone after conservative treatment or contra-lateral tumor;
• Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
• Concomitant hormonal therapy for metastatic breast cancer;
• Prior chemotherapy in the metastatic setting;
• Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
• Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Capecitabine; Gemcitabine; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Gustavo Villanova M.D
• Organization: Pierre Fabre

gustavo.villanova@pierre-fabre.com

+33149108265

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: March 22, 2019
• Study Start: March 27, 2007
• Primary Completion: April 18, 2013
• Study Completion: April 18, 2013
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-02