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Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

Primary Purpose

Breast Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vinorelbine
Gemcitabine
Sponsored by
Spanish Breast Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Drug-resistant metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Spanish Breast Cancer Research Group (GEICAM)
  • Grupo Andino de Investigación en Oncología (GAICO)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Vinorelbine

Arm B: Vinorelbine and Gemcitabine

Arm Description

Arm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8.

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.

Outcomes

Primary Outcome Measures

Progression-free survival
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.

Secondary Outcome Measures

The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests. Adverse events grade were defined by the NCI CTCAE v2.0.
Objective Response Rate (ORR)
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.
Response Duration (RD)
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.
Overall Survival (OS)
OS was defined as the time elapsed from first treatment until death from any cause.

Full Information

First Posted
August 8, 2005
Last Updated
May 29, 2023
Sponsor
Spanish Breast Cancer Research Group
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00128310
Brief Title
Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients
Official Title
Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2001 (Actual)
Primary Completion Date
August 15, 2006 (Actual)
Study Completion Date
January 24, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Breast Cancer Research Group
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoplasm Metastasis
Keywords
Drug-resistant metastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Vinorelbine
Arm Type
Active Comparator
Arm Description
Arm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8.
Arm Title
Arm B: Vinorelbine and Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The Number of Participants Who Experienced Adverse Events (AE)
Description
Safety was assessed by standard clinical and laboratory tests. Adverse events grade were defined by the NCI CTCAE v2.0.
Time Frame
Through study completion, an average of 1 year
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Response Duration (RD)
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Overall Survival (OS)
Description
OS was defined as the time elapsed from first treatment until death from any cause.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Hospital San Carlos, Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Spanish Breast Cancer Research Group (GEICAM)
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28700
Country
Spain
Facility Name
Grupo Andino de Investigación en Oncología (GAICO)
City
Valencia
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
17329192
Citation
Martin M, Ruiz A, Munoz M, Balil A, Garcia-Mata J, Calvo L, Carrasco E, Mahillo E, Casado A, Garcia-Saenz JA, Escudero MJ, Guillem V, Jara C, Ribelles N, Salas F, Soto C, Morales-Vasquez F, Rodriguez CA, Adrover E, Mel JR; Spanish Breast Cancer Research Group (GEICAM) trial. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol. 2007 Mar;8(3):219-25. doi: 10.1016/S1470-2045(07)70041-4.
Results Reference
derived
Links:
URL
http://www.geicam.org
Description
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Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

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