NCT00128310 is a Phase 3 clinical trial of Vinorelbine in Breast Cancer, sponsored by Spanish Breast Cancer Research Group.

Who is sponsoring NCT00128310?

NCT00128310 is sponsored by Spanish Breast Cancer Research Group.

What drugs are being tested in NCT00128310?

Interventions in NCT00128310: Vinorelbine, Gemcitabine.

What condition does NCT00128310 study?

NCT00128310 studies Breast Cancer, Neoplasm Metastasis.

Is NCT00128310 still recruiting?

NCT00128310 is currently completed. Last updated 31 May 2023.

Last reviewed 2023-05-31 · How we verify

NCT00128310

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

Completed Phase 3 Last updated 31 May 2023

What this trial tests

Phase 3 trial testing Vinorelbine in Breast Cancer in 252 participants. Completed in 24 January 2008.

Timeline

18 January 2001

Primary endpoint
15 August 2006

24 January 2008

Quick facts

Lead sponsor	Spanish Breast Cancer Research Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	252
Start date	18 January 2001
Primary completion	15 August 2006
Estimated completion	24 January 2008
Sites	2 locations across Venezuela, Spain

Drugs / interventions tested

Vinorelbine (vinorelbine) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →

Sponsor

Spanish Breast Cancer Research Group

Who can join

18 and older, female only, with Breast Cancer or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Martín M, Ruiz A, Muñoz M, Balil A, et al · · 2007 · cited 130× · PMID 17329192 · DOI 10.1016/s1470-2045(07)70041-4

Verify or expand the search:

Other trials of Vinorelbine

Trials testing the same drug.

NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07021989 — ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma · Phase 2 · not yet recruiting
NCT07461454 — YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT06908993 — Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Trea · Phase 3 · recruiting
NCT06908304 — A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC · Phase 3 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Spanish Breast Cancer Research Group trials

Trials by the same sponsor.

NCT07478939 — Study on the Level of Physical Activity in Patients Diagnosed With Breast Cancer in Spain · completed
NCT05744375 — Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab · Phase 2 · terminated
NCT05583110 — Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non · Phase 2 · terminated
NCT04293393 — Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients · Phase 2 · active not recruiting
NCT03800355 — Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00128310 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spanish Breast Cancer Research Group
Last refreshed: 31 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00128310.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing