NCT00047255 is a Phase 3 clinical trial of trastuzumab in Breast Cancer, sponsored by Jonsson Comprehensive Cancer Center.

Who is sponsoring NCT00047255?

NCT00047255 is sponsored by Jonsson Comprehensive Cancer Center.

What drugs are being tested in NCT00047255?

Interventions in NCT00047255: trastuzumab, carboplatin, docetaxel, trastuxumab, Docetaxel.

What condition does NCT00047255 study?

NCT00047255 studies Breast Cancer.

Is NCT00047255 still recruiting?

NCT00047255 is currently completed. Last updated 30 July 2020.

Last reviewed 2020-07-30 · How we verify

NCT00047255

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

A Multicenter Phase III Randomized Trial Comparing Docetaxel (Taxotere) and Trastuzumab (Herceptin) With Docetaxel (Taxotere), Carboplatin and Trastuzumab (Herceptin) as First Line Chemotherapy for Patients With Advanced Breast Cancer Containing the HER2 Gene Amplification

Completed Phase 3 Last updated 30 July 2020

What this trial tests

Phase 3 trial testing trastuzumab in Breast Cancer in 263 participants. Completed in 1 April 2010.

Timeline

1 May 2002

Primary endpoint
1 January 2006

1 April 2010

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	263
Start date	1 May 2002
Primary completion	1 January 2006
Estimated completion	1 April 2010
Sites	1 location across United States

Drugs / interventions tested

trastuzumab (trastuzumab) — full drug profile →
carboplatin (Carboplatin) — full drug profile →
docetaxel (Docetaxel) — full drug profile →
trastuxumab — full drug profile →
Docetaxel (Docetaxel) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

Adults 18 to 75, 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.

Evaluate time to disease progression after treatment with either Herceptin in with single-agent docetaxel (TH) or Herceptin with Carboplatin and TH in metastatic breast cancer pts previously untreated with chemo whose cancer contains the HER2 gene amp.
Time frame: till disease progression

Sponsor's own description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if docetaxel and trastuzumab are more effective with or without carboplatin in treating women who have HER2-positive breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combining docetaxel and trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB or stage IV breast cancer.

Publications & conference data

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

Platinum-containing regimens for metastatic breast cancer.
Egger SJ, Willson ML, Morgan J, Walker HS, et al · · 2017 · cited 33× · PMID 28643430 · DOI 10.1002/14651858.cd003374.pub4
Trastuzumab combined with doublet or single-agent chemotherapy as first-line therapy for HER2-positive metastatic breast cancer.
Yu YF, Wang Y, Fu TP, Chen K, et al · · 2018 · cited 6× · PMID 29188398 · DOI 10.1007/s10549-017-4592-y
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 trials of trastuzumab

Trials testing the same drug.

NCT07335081 — ctDNA in HER2+ EBC Neoadjuvant Treatment · Phase 2 · recruiting
NCT06278870 — Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial · Phase 3 · recruiting
NCT07421141 — De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer · Phase 2 · active not recruiting
NCT05253651 — A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colo · Phase 3 · recruiting
NCT05091528 — A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers · Phase 1, PHASE2 · terminated

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 Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet 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 NCT00047255 (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 Jonsson Comprehensive Cancer Center
Last refreshed: 30 July 2020

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/NCT00047255.

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