NCT00590785 is a Phase 3 clinical trial of Doxorubicin in High Risk, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT00590785?

NCT00590785 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00590785?

Interventions in NCT00590785: Doxorubicin, Cyclophosphamide, G-CSF, tamoxifen, ciprofloxacin.

What condition does NCT00590785 study?

NCT00590785 studies High Risk, Breast Cancer, Positive Nodes, Cyclophosphamide, Doxorubicin.

Is NCT00590785 still recruiting?

NCT00590785 is currently completed. Last updated 25 August 2017.

Last reviewed 2017-08-25 · How we verify

NCT00590785

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

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

Completed Phase 3 Last updated 25 August 2017

What this trial tests

Phase 3 trial testing Doxorubicin in High Risk in 60 participants. Completed in 13 January 2015.

Timeline

13 August 1996

Primary endpoint
10 June 1997

13 January 2015

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	13 August 1996
Primary completion	10 June 1997
Estimated completion	13 January 2015
Sites	1 location across United States

Drugs / interventions tested

Doxorubicin (doxorubicin) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
G-CSF
tamoxifen
ciprofloxacin (Ciprofloxacin) — full drug profile →

Conditions studied

High Risk — all drugs for High Risk →
Breast Cancer — all drugs for Breast Cancer →
Positive Nodes — all drugs for Positive Nodes →
Cyclophosphamide — all drugs for Cyclophosphamide →

Sponsor

National Cancer Institute (NCI)

Who can join

Eligibility, female only, with High Risk or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk primary breast cancer patients with negative axillary lymph nodes or with one to three positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by cyclophosphamide (A--\>C).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Doxorubicin

Trials testing the same drug.

NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT06738368 — Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombin · Phase 2 · recruiting
NCT07493148 — Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL · Phase 2 · recruiting
NCT07278856 — Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphoma · Phase 1 · not yet recruiting

Other recruiting trials for High Risk

Currently open trials in the same condition.

NCT07124325 — Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care · NA · recruiting
NCT06624696 — Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane An · Phase 4 · recruiting
NCT06409702 — Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection · Phase 4 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · 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 NCT00590785 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 25 August 2017

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/NCT00590785.

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