Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

May 29, 2023 updated by: Spanish Breast Cancer Research Group

Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes

This is a multicenter, randomized, prospective, Phase III study in which patients with advanced breast carcinoma previously treated with anthracyclines and taxanes will be randomly assigned to receive one of two treatment options: vinorelbine (Arm A) or gemcitabine plus vinorelbine (Arm B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators assume that progression-free survival mean time for patients treated with vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will be 5 months. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60% of patients have progressed after 1 year, the number of patients needed per treatment arm is 114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126 per arm).

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • San Sebastián de los Reyes, Madrid, Spain, 28700
        • Spanish Breast Cancer Research Group (GEICAM)
  • Venezuela
      • Valencia, Venezuela
        • Grupo Andino de Investigación en Oncología (GAICO)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological or cytological diagnoses of breast cancer, with metastases.
  • Metastatic lesions should not be curable with surgery or radiotherapy.
  • Women of age > 18.
  • To have received a previous treatment with anthracyclines and taxanes.
  • A maximum of 2 previous chemotherapy treatment lines for metastatic disease.
  • Previous radiotherapy is allowed, whenever the radiated area is not the only disease location.
  • At least 4 weeks since the last previous antineoplastic treatment; patient must have recovered from all previous toxicities.
  • Performance status < 2 in World Health Organization (WHO) scale.
  • Clinically measurable, non measurable or really non measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Life expectancy of at least 12 weeks.
  • Patients able to comply and to receive an adequate follow-up.
  • Adequate bone marrow function: neutrophils ≥ 2 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin ≥ 100 g/L.
  • Calcium within normal limits.
  • Premenopausal women must adopt an adequate contraceptive method during the study and up to 3 months after treatment finalization.

Exclusion Criteria:

  • Active infection or serious concomitant disease (investigator's criteria).
  • Clinical evidence of metastases in the central nervous system (CNS).
  • Blastic bone lesions as only disease.
  • Previous neurological toxicity grade 3-4 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v.2.0.
  • Previous treatment with gemcitabine and/or vinorelbine.
  • More than 2 previous chemotherapy treatment lines for metastatic disease.
  • Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); alanine transaminase (ALT) and aspartate transaminase (AST) >2.5-fold UNL). In patients with hepatic metastasis, a value of ALT and AST of up to 5-fold UNL is permitted.
  • Unpaired renal function (creatinine > 2.0 mg/dL).
  • Pregnancy or lactating.
  • Treatment with any investigational agent in the previous 4 weeks.
  • Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma.
  • Males.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Vinorelbine
Arm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8.
Drug: Vinorelbine
Other Names:
  • Navelbine
Experimental: Arm B: Vinorelbine and Gemcitabine
Arm B: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8. Gemcitabine will be administered following vinorelbine at a dose of 1200 mg/m2 as an intravenous infusion over 30 minutes.
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Vinorelbine
Other Names:
  • Navelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Through study completion, an average of 1 year
Progression-free survival is calculated as the time from randomization to the first observation of disease progression or date of death (whichever occurs earlier). Progression-free survival time will be censored at the time of the most recent information for patients who are still alive at the time of the last visit.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Who Experienced Adverse Events (AE)
Time Frame: Through study completion, an average of 1 year
Safety was assessed by standard clinical and laboratory tests. Adverse events grade were defined by the NCI CTCAE v2.0.
Through study completion, an average of 1 year
Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 1 year
Tumor response will be assessed using RECIST criteria. The best response across all treatment will be recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
Through study completion, an average of 1 year
Response Duration (RD)
Time Frame: Through study completion, an average of 1 year
RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. For responding patients not known to have died as of the data cut-off date and who do not have progression, duration of response will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, duration of response will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
Through study completion, an average of 1 year
Overall Survival (OS)
Time Frame: Through study completion, an average of 1 year
OS was defined as the time elapsed from first treatment until death from any cause.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Breast Cancer Research Group

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Study Director, Hospital San Carlos, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2001

Primary Completion (Actual)

August 15, 2006

Study Completion (Actual)

January 24, 2008

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimated)

August 9, 2005

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEICAM 2000-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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