Breast Cancer Patients Treated With Myelosuppressive Chemotherapy Clinical Trial
— PROTECT-1Official title:
A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
| Verified date | November 2016 |
| Source | Sandoz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ministry of Health of the Russian Federation |
| Study type | Interventional |
The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
| Status | Completed |
| Enrollment | 318 |
| Est. completion date | September 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - histologically proven breast cancer - eligible for six cycles of neoadjuvant or adjuvant chemotherapy Exclusion Criteria: - concurrent or prior chemotherapy for breast cancer - concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy - concurrent prophylactic antibiotics - previous therapy with any G-CSF (granulocyte-colony stimulating factor) product Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Sandoz Investigational Site | Ijui | |
| Brazil | Sandoz Investigational Site | Lajeado | |
| Brazil | Sandoz Investigational Site | Santo Andre | |
| India | Sandoz Investigational Site | Andhra Pradesh | |
| India | Sandoz Investigational Site | Delhi | |
| India | Sandoz Investigational Site | Madurai | |
| India | Sandoz Investigational Site | Maharashtra | |
| India | Sandoz Investigational Site | Maharashtra | |
| India | Sandoz Investigational Site | Maharashtra | |
| India | Sandoz Investigational Site | Mumbai | |
| India | Sandoz Investigational Site | Rajasthan | |
| Mexico | Sandoz Investigational Site | Aguascalientes | |
| Mexico | Sandoz Investigational Site | Juchitan | |
| Romania | Sandoz Investigational Site | Bucharest | |
| Romania | Sandoz Investigational Site | Bucharest | |
| Romania | Sandoz Investigational Site | Iasi | |
| Romania | Sandoz Investigational Site | Suceava | |
| Russian Federation | Sandoz Investigational Site | Barnaul | |
| Russian Federation | Sandoz Investigational Site | Bashkortostan | |
| Russian Federation | Sandoz Investigational Site | Berdsk | |
| Russian Federation | Sandoz Investigational Site | Ivanovo | |
| Russian Federation | Sandoz Investigational Site | Kabardino | |
| Russian Federation | Sandoz Investigational Site | Kazan | |
| Russian Federation | Sandoz Investigational Site | Krasnodar | |
| Russian Federation | Sandoz Investigational Site | Kursk | |
| Russian Federation | Sandoz Investigational Site | Leningrad | |
| Russian Federation | Sandoz Investigational Site | Moscow | |
| Russian Federation | Sandoz Investigational Site | Novgorod | |
| Russian Federation | Sandoz Investigational Site | Oktyabrskaya | |
| Russian Federation | Sandoz Investigational Site | Ryazan | |
| Russian Federation | Sandoz Investigational Site | St. Petersburg | |
| Russian Federation | Sandoz Investigational Site | Tula | |
| Ukraine | Sandoz Investigational Site | Cherkasy | |
| Ukraine | Sandoz Investigational Site | Chernivtsi | |
| Ukraine | Sandoz Investigational Site | Dnipropetrovsk | |
| Ukraine | Sandoz Investigational Site | Kharkiv | |
| Ukraine | Sandoz Investigational Site | Kriviy Rig | |
| Ukraine | Sandoz Investigational Site | Lugansk | |
| Ukraine | Sandoz Investigational Site | Mariupol | |
| Ukraine | Sandoz Investigational Site | Vinnytsya | |
| Ukraine | Sandoz Investigational Site | Zaporizhzhia |
| Lead Sponsor | Collaborator |
|---|---|
| Sandoz |
Brazil, India, Mexico, Romania, Russian Federation, Ukraine,
Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, Nakov R, Singh P, Rudy A, Blackwell K. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016 Jun;12( — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy | Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia. | 21 days (Cycle 1 of chemotherapy treatment) | Yes |
| Secondary | Incidence of febrile neutropenia | To assess the safety of LA-EP2006 and Peg-Filgrastim. | 4 months | Yes |
| Secondary | Incidence, occurrence and severity of (serious) adverse events. | 10 months | Yes |