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NCT02115984
Double-blind Multicenter Placebo-controlled Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer
Phase 2 trial testing Panagen in Breast Cancer in 80 participants. Completed in 1 May 2012.
1 May 2012
Quick facts
| Lead sponsor | Panagen, Limited Liability Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2010 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
Drugs / interventions tested
- Panagen — full drug profile →
- Placebo
- Chemotherapy (chemotherapy) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Panagen, Limited Liability Company — full company profile →
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.
-
The Quantity of Leukocytes and Neutrophils in the Blood of Patients
Time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)
Sponsor's own description
The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with distant metastases).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast cancer.
Proskurina AS, Gvozdeva TS, Alyamkina EA, Dolgova EV, et al · · 2015 · cited 4× · PMID 25886605 · DOI 10.1186/s12885-015-1142-z -
Five-year disease-free survival among stage II-IV breast cancer patients receiving FAC and AC chemotherapy in phase II clinical trials of Panagen.
Proskurina AS, Gvozdeva TS, Potter EA, Dolgova EV, et al · · 2016 · cited 3× · PMID 27538465 · DOI 10.1186/s12885-016-2711-5
Verify or expand the search:
- PubMed search for NCT02115984
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- 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
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 NCT02115984 (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 Panagen, Limited Liability Company
- Last refreshed: 11 June 2014
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/NCT02115984.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing