None listed
Conditions
Interventions
Group 1 Type of group
Standard Chemotherapy, epoetin alfa 40000 IU s.c. once a week plus Standard Support Therapy (Concentrated RBC Transfusions)
Group name:Group 2 Type of group
Standard Chemotherapy plus Standard Support Therapy (concentrated RBC transfusions)
Sponsors
JHONSON & JHONSON PHARMACEUTICALS,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Women with breast cancer confirmed histologically (in initial diagnosis) and with clinical evidence of metastasis. It is recommended to have cytological or biopsy confirmation of new metastatic lesions (for example, new peripheral pulmonary lesions) but it is optional depending on the practices of the center. • The subjects (or their legal representatives) must have signed an informed consent document indicating that they understand the purpose and procedures required for the study and that they wish to participate in the study. • At least 1 measurable metastatic lesion with or without non-measurable lesions (such as bone metastasis), quantified by appropriate imaging. Subjects who have only non-measurable lesions (such as malignant pleural effusion, malignant ascites) are not eligible. • Over 18 years • Weight> 40 Kg • The performance rating of the Eastem Cooperativa Oncology Group (ECOG) from O to 1 (Annex 2) • Life expectancy> 6 months, based on the clinical judgment of the researcher. • Subjects must be surgically sterile, postmenopausal for at least 1 year or practicing an effective birth control method (eg, intrauterine device, double barrier methods, male partner sterilization) for at least 30 days prior to randomization , at the same time that they receive chemotherapy or epoetin alfa, and for 12 weeks (3 months) after the last dose of chemotherapy or epoetin alfa. They should have a negative serum b-hCG pregnancy test 1 week before randomization and negative urine pregnancy test at the day of randomization. NOTE: Estrogen-based contraceptives are contraindicated in subjects with breast cancer and medroxyprogesterone acetate is a known risk factor for TVE • Plan to receive at least 4 cycles of chemotherapy while in the study. • Any of the following: - That they plan to initiate first-line chemotherapy against metastatic breast cancer every 3 weeks or weekly, with a baseline Hb 1.5 x 10 ^ / L before the start of chemotherapy or> 1.0 x 10 ^ / L in subjects who already receive che
Exclusion criteria
Exclusion criteria: • History of: - A second active cancer, except for properly treated skin cancer and cervical cancer in situ - Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 12 months before entering the study. Previous superficial thrombophlebitis is not a criterion for exclusion from the study. - Infarction, transient ischemic attack (TIA), acute coronary syndrome (ACS) or other arterial thrombosis in the 6 months prior to study entry. The ACS includes unstable angina, Q-wave myocardial infarction (QwMI) and non-Q-wave myocardial infarction (NQMI) - Being prophylactic or therapeutic anticoagulants at the moment. The only exception is low-dose aspirin ( 180 mmHg, diastolic> 100 mmHg) while receiving anti-hypertensive therapy - Anemia secondary to vitamin B12 deficiency, folate, or iron. If the mean corpuscular volume (MCV) is> 100, a deficiency of vitamin B12 and folate must be ruled out. - Anemia known as secondary to gastrointestinal bleeding, hemolysis (acquired or hereditary, such as sickle cell syndrome and thalassemia syndrome) or primary syndrome. of myelodysplasia - Presence of other co-morbid conditions or diseases of the cardiovascular, respiratory, renal or other systems that compromise the administration of the planned chemotherapy. • Previous use of therapy with ESA (epoetin alfa, epoetin beta, epoetin delta, epoetin omega or darbepoetin) in the 2 months prior to randomization, lack of response to therapy with ESA or use of an ESA in research at some time. • Ongoing treatment with anticoagulants against TVE. Have received an experimental drug or use an experimental medical device in the adjuvant / neoadjuvant therapy scheme within 30 days prior to the planned start of treatment • Pregnant or nursing subjects • If the site of the metastasis is only local and was completely removed (for example, isolated soft tissue injury) • If the bone is the only site of metastasis • Progressive disease during adjuvant / adjuvant chemotherapy • If the HER2 / NEU tests have not been carried out and therefore the HER2 / NEU status is unknown • Patients already receiving first-line chemotherapy for metastatic breast cancer should receive an accepted regimen as specified in section 6.3 and table 5 before reaching Hb <11 g / dL, and there should be no evidence of progression of the illness. Formal communication and sponsor approval is required so that patients in regimens not listed in Table 5 may be eligible for this study and randomized. • Subjects who have previously received or are receiving dose intensification (high dose) chemotherapy regimens for bone marrow transplantation or peripheral blood precursor cells • Simultaneous endocrine therapy (such as tamoxifen, aromatase inhibitors, luteinizing hormone-releasing hormone [LHRH] agonists) during first-line chemotherapy against metastatic breast cancer • Fertile women who do not want to use an adequate contraceptive during treatment and for up to 12 weeks (3 months) after the last dose of chemotherapy or epoetin alfa. Intrauterine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:it is measured in months from the date of Randomization to the date of the first documented case of progression or death, whichever occurs first. Subjects who survive without progression at the time of clinical cessation will be counted with the date of their last tumor evaluation. Measure:Progression Free Survival (PFS) Timepoints:months from the date of Randomization to the date of the first documented case of progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be based on the calculation of the odds ratio (epoetin alfa versus control) and its 95% confidence interval using adjusted logistic regression for stratification of variables. An exploratory logistic regression model that includes other forecast variables to analyze the ORR will also be used. Measure:Global Response Timepoints:After treatment ; Outcome name:In the case of subjects with total or partial response, the duration of this will be measured in months from the date of documentation of the response and until the date of the first documented progression or death, whichever occurs first. Those who respond and survive without progression at the time of clinical cessation will be counted with the dates of their last evaluation of the tumor. Since this analysis is based on a subgroup determined by the result of the tumor response, only descriptive statistics will be provided. Measure:Duration of the Response Timepoints:measured in months from the date of documentation of the response and until the date of the first documented progression or death ; Outcome name:The time of tumor progression (TTP) is measured in months from the date of randomization to the date of death. Subjects who survive the moment of clinical cessation will be counted with the date of their last evaluation. The TTP will be analyzed in a similar way to the PFS. Measure:Tumor Progression Time Timepoints:months from the date of randomization to the date of death ; Outcome name:Overall survival is measured in months from the Randomization date to the date of death. Subjects who live at the time of clinical closure will be counted with the date of their last observation. The OS will be analyzed in a similar way to the PFS. Measure:Global Survival Timepoints:months from the Randomization date to the date of death ; Outcome name:Vascular thromboembolic events will be classified as total TVE, clinically relevant TVE, TVE | — |
Countries
Bulgaria, Chile, Colombia, Ecuador, Georgia, India, Macedonia, Russian Federation, Taiwan, Ukraine, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed