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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

Completed Phase 2 Results posted Last updated 11 June 2014
What this trial tests

Phase 2 trial testing Panagen in Breast Cancer in 80 participants. Completed in 1 May 2012.

Timeline
1 May 2010
Primary endpoint
1 May 2012
1 May 2012

Quick facts

Lead sponsorPanagen, Limited Liability Company
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment80
Start date1 May 2010
Primary completion1 May 2012
Estimated completion1 May 2012

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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

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