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NCT01033032
Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer
Phase 1/Phase 2 trial testing Amrubicin in Metastatic Breast Cancer in 78 participants. Completed in 1 October 2014.
1 July 2013
Quick facts
| Lead sponsor | SCRI Development Innovations, LLC |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 1 December 2009 |
| Primary completion | 1 July 2013 |
| Estimated completion | 1 October 2014 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- Amrubicin — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
SCRI Development Innovations, LLC — full company profile →
Who can join
18 and older, female only, with Metastatic 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.
-
Progression-Free Survival (PFS) of MTD/Phase II Patients
Time frame: every 6 weeks until progressive disease
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. This outcome
Sponsor's own description
Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
DNA topoisomerases as molecular targets for anticancer drugs.
Buzun K, Bielawska A, Bielawski K, Gornowicz A. · · 2020 · cited 91× · PMID 32975138 · DOI 10.1080/14756366.2020.1821676
Verify or expand the search:
- PubMed search for NCT01033032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amrubicin
Trials testing the same drug.
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- NCT05740566 — Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer · Phase 3 · active not recruiting
- NCT02481830 — Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer · Phase 3 · completed
- NCT00915083 — A Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Can · Phase 1 · completed
- NCT00547651 — AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy · Phase 3 · completed
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other SCRI Development Innovations, LLC trials
Trials by the same sponsor.
- NCT04699630 — A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer · Phase 2 · completed
- NCT04402138 — Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma · Phase 2 · completed
- NCT04200365 — A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) · Phase 2 · terminated
- NCT04209725 — A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia · Phase 2 · terminated
- NCT04361058 — Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01033032 (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 SCRI Development Innovations, LLC
- Last refreshed: 5 April 2022
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/NCT01033032.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing