NCT00128778 is a Phase 4 clinical trial of Pegylated liposomal doxorubicin in Breast Neoplasms, sponsored by Spanish Breast Cancer Research Group.

Who is sponsoring NCT00128778?

NCT00128778 is sponsored by Spanish Breast Cancer Research Group.

What drugs are being tested in NCT00128778?

Interventions in NCT00128778: Pegylated liposomal doxorubicin.

What condition does NCT00128778 study?

NCT00128778 studies Breast Neoplasms.

Is NCT00128778 still recruiting?

NCT00128778 is currently completed. Last updated 6 March 2023.

Last reviewed 2023-03-06 · How we verify

NCT00128778

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

Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

Completed Phase 4 Last updated 6 March 2023

What this trial tests

Phase 4 trial testing Pegylated liposomal doxorubicin in Breast Neoplasms in 288 participants. Completed in 7 July 2010.

Timeline

28 October 2002

Primary endpoint
1 June 2007

7 July 2010

Quick facts

Lead sponsor	Spanish Breast Cancer Research Group
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	288
Start date	28 October 2002
Primary completion	1 June 2007
Estimated completion	7 July 2010
Sites	1 location across Spain

Drugs / interventions tested

Pegylated liposomal doxorubicin

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Spanish Breast Cancer Research Group

Who can join

Adults 18 to 90, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.

Publications & conference data

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

The Role of <i>in silico</i> Research in Developing Nanoparticle-Based Therapeutics.
Jayasinghe MK, Lee CY, Tran TTT, Tan R, et al · · 2022 · cited 22× · PMID 35373184 · DOI 10.3389/fdgth.2022.838590

Verify or expand the search:

Other trials of Pegylated liposomal doxorubicin

Trials testing the same drug.

NCT06981637 — Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Contr · Phase 2 · recruiting
NCT06843447 — A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) · Phase 1, PHASE2 · recruiting
NCT06072781 — A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer · Phase 3 · recruiting
NCT06023862 — A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurr · Phase 2 · recruiting
NCT05870748 — REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) C · Phase 2, PHASE3 · terminated

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · 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 NCT00128778 (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: 6 March 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/NCT00128778.

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