Who is sponsoring NCT01612247?

NCT01612247 is sponsored by University of Vermont.

What drugs are being tested in NCT01612247?

Interventions in NCT01612247: Cyclophosphamide and Methotrexate and Aspirin.

What condition does NCT01612247 study?

NCT01612247 studies Breast Cancer.

Is NCT01612247 still recruiting?

NCT01612247 is currently status unknown. Last updated 4 June 2012.

Last reviewed 2012-06-04 · How we verify

NCT01612247

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

Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy

Status unknown NA Last updated 4 June 2012

What this trial tests

NA trial testing Cyclophosphamide and Methotrexate and Aspirin in Breast Cancer in 13 participants. Status unknown.

Timeline

1 February 2011

Primary endpoint
1 February 2013

1 February 2014

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	13
Start date	1 February 2011
Primary completion	1 February 2013
Estimated completion	1 February 2014
Sites	3 locations across United States

Drugs / interventions tested

Cyclophosphamide and Methotrexate and Aspirin — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Vermont

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.

Toxicity and Safety
Time frame: 18 months
The primary endpoint of the study is toxicity and safety. Serious adverse events, grade 3 and 4 nonhematologic toxicity, and hematologic toxicity requiring removal of the patient from study treatment will be reviewed. A fixed sample size design to test for primary toxicity events will be conducted. Sample size was selected based upon a null hypothesis that the toxicity rate will be 5% or less and

Sponsor's own description

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.

Publications & conference data

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

Trial Watch-Small molecules targeting the immunological tumor microenvironment for cancer therapy.
Buqué A, Bloy N, Aranda F, Cremer I, et al · · 2016 · cited 44× · PMID 27471617 · DOI 10.1080/2162402x.2016.1149674
Trial Watch: Radioimmunotherapy for oncological indications.
Bloy N, Pol J, Manic G, Vitale I, et al · · 2014 · cited 41× · PMID 25941606 · DOI 10.4161/21624011.2014.954929
Natural Products for the Prevention, Treatment and Progression of Breast Cancer.
Svolacchia F, Brongo S, Catalano A, Ceccarini A, et al · · 2023 · cited 12× · PMID 37296944 · DOI 10.3390/cancers15112981

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

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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 University of Vermont trials

Trials by the same sponsor.

NCT07495098 — Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer · Phase 1 · not yet recruiting
NCT07440641 — RE-FIT (Remote Exercise for Physical Function in WTC Responders With Prostate Cancer) · NA · not yet recruiting
NCT06993129 — A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants Wi · NA · not yet recruiting
NCT07383727 — Readiness to Change and the Implementation of Home Modifications for Adults Over 60 · NA · not yet recruiting
NCT06670079 — Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients · 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 NCT01612247 (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 University of Vermont
Last refreshed: 4 June 2012

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/NCT01612247.

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