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NCT02674204: STOP
STOP Heart Disease in Breast Cancer Survivors Trial
Phase 2 trial testing Atorvastatin in Breast Cancer in 2 participants. Terminated before completion.
25 May 2018
Quick facts
| Lead sponsor | Cedars-Sinai Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 5 May 2016 |
| Primary completion | 25 May 2018 |
| Estimated completion | 25 May 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Atorvastatin (atorvastatin) — full drug profile →
- Placebo
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Heart Disease — all drugs for Heart Disease →
- Cardiotoxicity — all drugs for Cardiotoxicity →
- Myocardial Dysfunction — all drugs for Myocardial Dysfunction →
Sponsor
Cedars-Sinai Medical Center
Who can join
18 and older, female only, with Breast Cancer or Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over the 12-month intervention period and within 30 days of the last administration of the study drug.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | Study Agent | Control |
|---|---|---|---|
| colitis | Gastrointestinal disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
Other adverse events (22 terms — click to expand)
| Reaction | System | Study Agent | Control |
|---|---|---|---|
| alanine aminotransferase increased | Investigations | — | — |
| arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| aspartate aminotransferase increased | Investigations | — | — |
| myalgia | Musculoskeletal and connective tissue disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| insomnia | Psychiatric disorders | — | — |
| dyspepsia | Gastrointestinal disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| neuralgia | Nervous system disorders | — | — |
| abdominal cramping | Gastrointestinal disorders | — | — |
| fatigue | General disorders | — | — |
| pain | General disorders | — | — |
| hot flashes | Reproductive system and breast disorders | — | — |
| dizziness | Nervous system disorders | — | — |
| mood changes | Psychiatric disorders | — | — |
| upper respiratory tract infection | Infections and infestations | — | — |
| abdominal infection | Infections and infestations | — | — |
| vitamin D deficiency | General disorders | — | — |
| osteoporosis | Musculoskeletal and connective tissue disorders | — | — |
| somnolence | Nervous system disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
Most-reported serious reactions: colitis, diarrhea.
Data from ClinicalTrials.gov NCT02674204 adverse events section.
Sponsor's own description
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cardio-oncology: an overview on outpatient management and future developments.
Teske AJ, Linschoten M, Kamphuis JAM, Naaktgeboren WR, et al · · 2018 · cited 29× · PMID 30141030 · DOI 10.1007/s12471-018-1148-7 -
Protecting the heart in cancer therapy.
Finet JE, Tang WHW. · · 2018 · cited 14× · PMID 30345014 · DOI 10.12688/f1000research.15190.1
Verify or expand the search:
- PubMed search for NCT02674204
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Atorvastatin
Trials testing the same drug.
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- NCT07530289 — A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) · Phase 1 · not yet recruiting
- NCT07534592 — A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants · Phase 1 · not yet recruiting
- NCT07502001 — Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin · Phase 1 · not yet recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Cedars-Sinai Medical Center trials
Trials by the same sponsor.
- NCT06012487 — Correlates and Control of Blood Pressure Variability · Phase 1 · not yet recruiting
- NCT07495995 — SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis · Phase 2 · not yet recruiting
- NCT07413965 — TAVR vs SAVR in Severe Bicuspid Aortic Stenosis · NA · not yet recruiting
- NCT06521021 — CHOICE to AVOID or RESIST · NA · not yet recruiting
- NCT07499089 — Together-Breast Cancer Support Platform · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02674204 (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 Cedars-Sinai Medical Center
- Last refreshed: 15 May 2019
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/NCT02674204.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing