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

Breast Cancer Clinical Trial

Official title:

Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887130
• Other study ID #: PM0259CA223B0
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2007
• Est. completion date: April 18, 2013

Study information

• Verified date: February 2024
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 18, 2013
• Est. primary completion date: April 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• oral vinorelbine
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
• Capecitabine
Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
• Gemcitabine 1250 mg/m²
Gemcitabine 1250 mg/m² on day 1 & day 8
• Gemcitabine 1000 mg/m²
Gemcitabine: 1000 mg/m² on day 1 & 8
• Paclitaxel
Paclitaxel 175 mg/m² on day 1
• Docetaxel
Docetaxel 75 mg/m² on day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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