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The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
BCD-017-3 is an double-blind randomized phase III clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 6 or 7.5 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.
The study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empegfilgrastim 6 mg | Experimental | Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days |
|
| Empegfilgrastim 7.5 mg | Experimental | Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days |
|
| Filgrastim | Active Comparator | Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml subcutaneously, 24 h after the chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empegfilrastim 6 mg | Biological | Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Neutropenia CTCAE Grade 4 | The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel). | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12); | 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) | |
| The Incidence of Severe Neutropenia (Grade 3-4) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Ivanov, MD, PhD | Biocad | Study Director |
| Larisa Bolotina, MD, PhD | Federal State Institution "Moscow Research Oncological Institute P.A.Gertsena "of the Ministry of Health of the Russian Federation | Principal Investigator |
| Olga Brichkova, MD, PhD | State public health institution "Regional Oncology Dispensary №1 | Principal Investigator |
| Olga Burdaeva, MD | State Budget Institution of Health Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary" | Principal Investigator |
| Byakhov Michael, MD, PhD | Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways" | Principal Investigator |
| Vladimir Vladimirov, MD, PhD | State Budget Institution of Health Stavropol area "Piatigorsky Oncology Dispensary" | Principal Investigator |
| Rinat Galiulin, MD | State budget healthcare institution Omsk region "Clinical Oncology Dispensary" | Principal Investigator |
| Oleg Gladkov, MD, PhD | State Budget Institution of Health "Chelyabinsk Regional Clinical Oncology Dispensary" |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkhangelsk District Clinical Oncology Dispensary | Arkhangelsk | 163045 | Russia | |||
| Clinical Hospital at Chelyabinsk Railway Station |
7 patients were withdrawn for various reasons without receiving any dose of any of the studied products.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empegfilgrastim 6 mg | Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Filgrastim | Biological | Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir. |
|
|
| Placebo №1 | Biological | Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0. |
|
| Placebo №2 | Biological | Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. |
|
| Empegfilrastim 7.5 mg | Biological | Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg. |
|
|
| Low Level (Nadir) ANC x 10^9/L | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| Neutropenia Duration, Any Grade | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| Duration From ANC Nadir to ANC < 2.0 x 10^9/L | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| Principal Investigator |
| Irina Davydenko, PhD | State Budget Institution of Health "Clinical Oncology Dispensary № 1" of the Ministry of Health of the Krasnodar area | Principal Investigator |
| Victoria Elkova, MD | State public health institution "Voronezh Regional Clinical Oncology Dispensary" | Principal Investigator |
| Igor Lifirenko, MD | State public health institution "Kursk Regional Oncology Dispensary" | Principal Investigator |
| Nadezhda Kovalenko, PhD | State Budget Institution of Health "Volgograd regional oncologic dispensary № 3" | Principal Investigator |
| Michael Kopp, MD, PhD | State Budget Institution of Health "Samara Regional Clinical Oncology Dispensary" | Principal Investigator |
| Bogdan Kotiv, MD, PhD | S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation | Principal Investigator |
| Natalia Levchenko, PhD | State Budget Institution of Health Stavropol area "Stavropol Regional Clinical Oncology Dispensary" | Principal Investigator |
| Marina Matrosova, MD | State public health institution "Nizhny Novgorod Regional Oncology Dispensary" | Principal Investigator |
| Guzel Mukhametshina, MD | State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan | Principal Investigator |
| Sergei Panchenko, PhD | State public health institution "Regional Clinical Oncology Dispensary" | Principal Investigator |
| Alexander Pecheny, PhD | Regional State Health Care Institution "Orlovsky Oncology Dispensary" | Principal Investigator |
| Igor Pimenov, PhD | State Budget Institution health care "Tula Regional Oncology Dispensary" | Principal Investigator |
| Andrei Sinykov, PhD | State Health Care Institution of Tyumen Region "Regional Oncological Dispensary" | Principal Investigator |
| Pavel Skopin, PhD | Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva " | Principal Investigator |
| Daniil Stroyakovsky | State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department | Principal Investigator |
| Sergei Tyulyandin, MD, PhD | "Russian Oncological Scientific Center N.N.Blokhin" Russian Academy of Sciences | Principal Investigator |
| Dmitriy Udovica, MD | State Health Care Institution "Oncologic Dispensary № 2" Health Department of Krasnodar Area | Principal Investigator |
| Andrei Horinko, MD | State Health Care Institution "Perm Regional Oncology Dispensary" | Principal Investigator |
| Petr Krivorotko, MD | N.N. Petrov Oncology Research Center of the Ministry of Health of the Russian Federation | Principal Investigator |
| Yulia Shapovalova, PhD | Non-governmental healthcare institution "Chelyabinsk Road Clinical Hospital" JSC "Russian Railways" | Principal Investigator |
| Ludmila Sheveleva, MD | State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1" | Principal Investigator |
| Vadim Shirinkin, MD | State Health Care Institution "Orenburg Regional Clinical Oncology Dispensary" | Principal Investigator |
| Shekar Patil, MD | Bangalore Institute of Oncology | Principal Investigator |
| Prasad Narayanan, MD | Mazumdar Shaw Cancer Center and Narayana Hrudayalaya Multispecialty Hosptial | Principal Investigator |
| Nalini Kilara, MD | M.S.Ramaiah Memorial Hospital | Principal Investigator |
| Sergei Kulik, MD | Donetsk City Municipal Oncology Dispensary | Principal Investigator |
| Igor Sedakov, MD, PhD | Donetsk Regional oncology centers | Principal Investigator |
| Andrei Rusin, MD,PhD | Zakarpatskii Regional Clinical Oncology Dispensary | Principal Investigator |
| Yuri Vinnik, MD, PhD | Kharkiv Regional Clinical Oncology Center | Principal Investigator |
| Sergei Odarchenko, PhD | Vinnitskii Regional Oncology Dispensary | Principal Investigator |
| Chelyabinsk |
| Russia |
| State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan | Kazan' | Russia |
| Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways" | Moscow | Russia |
| State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department | Moscow | Russia |
| State public health institution "Nizhny Novgorod Regional Oncology Dispensary" | Nizhny Novgorod | Russia |
| Perm Region Oncology Dispensary | Perm | 614066 | Russia |
| Pyatigorsk Oncology Center | Pyatigorsk | 357502 | Russia |
| N.N.Petrov Oncology Research Center | Saint Petersburg | 197758 | Russia |
| Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva " | Saransk | Russia |
| State public health institution "Regional Clinical Oncology Dispensary" | Ulyanovsk | Russia |
| Volgograd Regional Oncology Dispensary №3 | Volgograd | 404130 | Russia |
| State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1" | Volgograd | Russia |
| FG001 |
| Empegfilgrastim 7.5 mg |
Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. |
| FG002 | Filgrastim | Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Empegfilgrastim 6 mg | Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg. Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. |
| BG001 | Empegfilgrastim 7.5 mg | Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg. |
| BG002 | Filgrastim | Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy. filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir. Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Histologic type | Number | participants |
| ||||||||||||||||
| Disease stage | Number | participants |
| ||||||||||||||||
| History previous therapy of breast cancer | Patients with previous therapy could be treated with several different types of therapy (for example surgery treatment and adjuvant chemotherapy) | Number | participants |
| |||||||||||||||
| Duration of a disease | Mean | Full Range | months |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Neutropenia CTCAE Grade 4 | The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel). | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Mean | Standard Deviation | days | 3 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12); | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Mean | Standard Deviation | days | 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Incidence of Severe Neutropenia (Grade 3-4) | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Number | participants | 16 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Low Level (Nadir) ANC x 10^9/L | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Mean | Standard Deviation | cells x 10^9/L | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Neutropenia Duration, Any Grade | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Mean | Standard Deviation | days | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration From ANC Nadir to ANC < 2.0 x 10^9/L | The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more. | Posted | Mean | Standard Deviation | days | 1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12) |
|
3 month
In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empegfilgrastim 6 mg | Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. | 1 | 42 | 42 | 42 | ||
| EG001 | Empegfilgrastim 7.5 mg | Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg. | 1 | 43 | 43 | 43 | ||
| EG002 | Filgrastim | Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0. | 5 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine bleeding | Reproductive system and breast disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Left hand fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
| |
| nose furunculus 3 grade | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia any grade | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Liver enzymes (ALT) elevation | Hepatobiliary disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Hyperemia after injection | Injury, poisoning and procedural complications | CTCAE (4.03) | Systematic Assessment |
| |
| Weakness / asthenia | General disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (4.03) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roman Ivanov, Director of Clinical Trials | Biocad | +7 (812) 380 49 33 | 950 | ivanov@biocad.ru |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D064147 | Febrile Neutropenia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Infiltrative lobular |
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| Medullar |
|
| Squamous cell cancer |
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| Infiltrative not specified |
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| Low-grade differentiated carcinoma |
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| Undifferentiated cancer |
|
| IIB |
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| IIIA |
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| IIIB |
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| IIIС |
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| IV |
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| Neoadjuvant chemotherapy |
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| Radiotherapy |
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| Hormone therapy |
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| Surgery treatment |
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| Any treatment |
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