NCT00337649 is a Phase 1/Phase 2 clinical trial of Epothilone D in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00337649?

NCT00337649 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00337649?

Interventions in NCT00337649: Epothilone D, Herceptin.

What condition does NCT00337649 study?

NCT00337649 studies Breast Cancer.

Is NCT00337649 still recruiting?

NCT00337649 is currently completed. Last updated 27 April 2023.

Last reviewed 2023-04-27 · How we verify

NCT00337649

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

An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer

Completed Phase 1/Phase 2 Last updated 27 April 2023

What this trial tests

Phase 1/Phase 2 trial testing Epothilone D in Breast Cancer in 27 participants. Completed in 1 July 2007.

Timeline

1 May 2004

Primary endpoint
1 July 2007

1 July 2007

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 May 2004
Primary completion	1 July 2007
Estimated completion	1 July 2007
Sites	6 locations across Spain

Drugs / interventions tested

Epothilone D — full drug profile →
Herceptin (trastuzumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Phase I: Number of Participants with a Dose-Limiting Toxicity
Time frame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
Time frame: From first dose of study treatment until documented response (up to 3 years, 2 months)

Sponsor's own description

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Repositioning Microtubule Stabilizing Drugs for Brain Disorders.
Varidaki A, Hong Y, Coffey ET. · · 2018 · cited 63× · PMID 30135644 · DOI 10.3389/fncel.2018.00226
Novel combinations for the treatment of metastatic breast cancer.
Vahdat LT. · · 2010 · cited 2× · PMID 24281029 · DOI 10.3390/cancers2010001

Verify or expand the search:

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 Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

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 NCT00337649 (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 Hoffmann-La Roche
Last refreshed: 27 April 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/NCT00337649.

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