None listed
Conditions
Interventions
Group 1 Type of group
Dasatinib will be administered orally at an initial dose of 70 mg BID. Her2 / neu amplified (regardless of the situation of RE / RPg
Group name:Group 2 Type of group
Dasatinib will be administered orally at an initial dose of 70 mg BID. Positive estrogen receptor (RE +) and / or positive progesterone receptor (RPg +)
Sponsors
BRISTOL MYERS SQUIBB PERU S.A., BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent signed according to the center´s rules. • Invasive breast cancer according to a previous biopsy with documented Her2 / neu amplification (regardless of the RE / RPg situation, Group A) or estrogen receptor and / or progesterone receptor (Group B); see detailed description in section 3.2.1 • A block of paraffin tissue must be available from a previous surgery • Locally advanced or metastatic disease, measurable, relapsing or progressive, assessed within 28 days prior to the start of treatment with the study drug (section 3.2). At least one objective lesion must be identified (section 3.3.2). • Previous chemotherapy including an anthracycline and / or a taxane and trastuzumab (Group A) and / or hormone therapy (in any of the groups) • No more than two chemotherapy regimens for metastatic disease • Recovery to grade lower limit of normality (LIN) c) K, Mg, serum phosphate, all grade 0 - 1 d) Creatinine grade 0 -2 e) Hemoglobin, neutrophil count, platelets, TP, TTP all grade 0-1 • Women,> 18 years old. Women of childbearing age (WOCBP) should use adequate contraception to avoid pregnancy throughout the study and up to 12 weeks after the study so that the risk of pregnancy is minimized
Exclusion criteria
Exclusion criteria: • Fertile women who do not want or can not use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 12 weeks after the study. • Pregnant or lactating women. • Women with a positive result in a pregnancy test at the time of inclusion or before the administration of the study drug. • Metastatic disease exclusively bone • Symptomatic metastases in the CNS (see section 7.2.1) • Any antineoplastic treatment, including radiotherapy or treatment with intravenous bisphosphonates in the 14 days prior to the start of the drug under study (21 days in the case of trastuzumab) • Another malignant tumor that required radiotherapy or systemic treatment in the previous 3 years • Concomitant medical problem that could increase the risk of toxicity • Prisoners or forcibly detained (involuntarily imprisoned) should not be included in the study for the treatment of psychiatric or physical illness (eg, infectious disease) • Inability to take oral medication for any reason • Inability to understand possible risks, and give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the proportion of patients evaluable in terms of response with CR or RP as the best response recorded during the study. Measure:Objective response rate (ORR) Timepoints:during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:TBI is defined as the proportion of subjects that can be evaluated in terms of response with CR or RP as the best response or with EE at or after 16 weeks in the study recorded during the study. Measure:Disease control rate (DCR) Timepoints:16 weeks ; Outcome name:The duration of the response will be defined as the time between the first date on which the CR or RP criteria are met and the first date on which EP is observed (including a CEP;) and analyzed in the subjects that achieve a RC or a RP. Measure:Duration of objective response Timepoints:During the study ; Outcome name:The duration of the control of the disease will be defined as the time from the date of the first dose until the first date on which PE is observed and will be carried out in the subjects that reach a CR, RP or EE. Measure:Duration of disease control Timepoints:During the study ; Outcome name:The SLP will be defined as the time from, the date of the first dose until the first date on which PE is observed and will be performed in all treated patients. Measure:Progression Free Survival (SLP) Timepoints:During the study | — |
Contacts
Public ContactJuanita Aching
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed