PHASE II STUDY OF DASATINIB (BMS-354825) IN ADVANCED BREAST CANCER RECEPTORS OF ESTROGEN / PROGESTERONE OR HER2 / NEU POSITIVE
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-080-07
- Lead Sponsor
- BRISTOL MYERS SQUIBB PERU S.A., BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 <1 of the toxicities of previous treatment (except alopecia)
• Functional status (ECOG) 0-1
• Adequate organic function (according to degrees of severity of CTCAE v.3.0). a) Liver enzymes (AST, ALT), total bilirubin, all grade 0-1 b) Serum ca> 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Objective response rate (ORR)<br>Timepoints:during the study.<br>
- Secondary Outcome Measures
Name Time Method