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AzTrials

Breast CancerPhase 3NCT00128310

Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

A Phase 3 study testing Vinorelbine and Gemcitabine in people with Breast Cancer and Neoplasm Metastasis, run by Spanish Breast Cancer Research Group at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Neoplasm Metastasis
What is being tested?
Vinorelbine and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
2 sitesin 2 countries
Study dates
18 Jan 2001to 24 Jan 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Spain1 site

  • Spanish Breast Cancer Research Group (GEICAM)

    San Sebastián de los Reyes, Madrid, 28700

Other trials in Spain

Venezuela1 site

  • Grupo Andino de Investigación en Oncología (GAICO)

    Valencia

Other trials in Venezuela

About this study

Official title: 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).

Read the 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).

Keywords
Drug-resistant metastatic breast cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00128310
Study groupRoleWhat they receive
Arm A: VinorelbineActive comparatorArm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8.
Receives: Drug: Vinorelbine
Arm B: Vinorelbine and GemcitabineExperimentalArm 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.
Receives: Drug: Vinorelbine; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. 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.

    Measured: Through study completion, an average of 1 year

  2. 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.

    Measured: Through study completion, an average of 1 year

  3. 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.

    Measured: Through study completion, an average of 1 year

  4. Overall Survival (OS)

    OS was defined as the time elapsed from first treatment until death from any cause.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2005 (estimated)
  2. Study start18 Jan 2001
  3. Primary completion15 Aug 2006
  4. Study completion24 Jan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00128310
Sponsor's protocol ID
GEICAM 2000-04
Status last verified
May 2023
First submitted
8 Aug 2005
Last updated
31 May 2023
Results posted
No

Publications

  • 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.

    PubMed 17329192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vinorelbine and Gemcitabine in people with Breast Cancer and Neoplasm Metastasis, run by Spanish Breast Cancer Research Group at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00128310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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