Calgb 40502 trial

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily. Skip to main content Thank you for visiting nature. Subjects Breast cancer Chemotherapy Combination drug therapy Randomized controlled trials.

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References 1 Cardoso, F. Article Google Scholar 3 Rugo, H. View author publications. Ethics declarations Competing interests The authors declare no competing financial interests. Rights and permissions Reprints and Permissions. About this article. Cite this article Gligorov, J. Copy to clipboard. Authors' disclosures of potential conflicts of interest are found in the article online at www. Author contributions are found at the end of this article. Supported in part by Grants No.

Disclosures provided by the authors are available with this article at www. Conception and design: Hope S. Rugo, William T. Perez, Clifford Hudis, Eric P. Provision of study materials or patients: Hope S. Lyss, Erica L. Carey, Clifford Hudis, Eric P. Collection and assembly of data: Hope S. Barry, Constance Cirrincione, Eleanor Leung. Data analysis and interpretation: Hope S.

Carey, Edith A. The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. Relationships may not relate to the subject matter of this manuscript.

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J Clin Oncol. Published online Jun 8. Rugo , William T. Carey , Edith A. Perez , Clifford Hudis , and Eric P. Rugo Hope S. Find articles by Hope S.

William T. Barry Hope S. Find articles by William T. Alvaro Moreno-Aspitia Hope S. Find articles by Alvaro Moreno-Aspitia. Alan P. Lyss Hope S. Find articles by Alan P. Constance Cirrincione Hope S. Find articles by Constance Cirrincione.

Eleanor Leung Hope S. Find articles by Eleanor Leung. Erica L. Mayer Hope S. Find articles by Erica L. Michael Naughton Hope S. Find articles by Michael Naughton. Deborah Toppmeyer Hope S. Find articles by Deborah Toppmeyer.

Lisa A. Carey Hope S. Find articles by Lisa A. Edith A. Perez Hope S. Find articles by Edith A. Clifford Hudis Hope S.

Find articles by Clifford Hudis. Eric P. Winer Hope S. Find articles by Eric P. Author information Copyright and License information Disclaimer. Corresponding author: Hope S. This article has been cited by other articles in PMC. Abstract Purpose We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer BC to evaluate progression-free survival PFS for nab-paclitaxel or ixabepilone versus paclitaxel.

Conclusion In patients with chemotherapy-naive advanced BC, ixabepilone once per week was inferior to paclitaxel, and nab-paclitaxel was not superior with a trend toward inferiority. Dose Modifications Dose levels and selected modifications are outlined in Appendix Table A1 online only ; re-escalation was not allowed.

Evaluation of Response Tumor imaging was repeated every two cycles; responses required 4-week confirmation. In the current work, an early time point that is predictive of the future severity of neuropathy was identified based on predictive accuracy of the model.

Using the early data and model parameters, simulations were conducted to propose a dose-adjustment algorithm for the prospective management of neuropathy in individual patients. Long-term modifications of plasma glucose concentration, as defined as changes in peripheral blood venous plasma glucose concentration measured before consecutive FMD cycles.

Short-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration before and after each FMD cycle.

Long-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration measured before consecutive FMD cycles.

Short-term modifications of blood lipid profile, as defined as changes in plasma lipids before and after individual FMD cycles. Long-term modifications of blood lipid profile, as defined as changes in plasma lipids assessed before consecutive FMD cycles.

To correlate baseline metabolic gene expression, as assessed through RNA-seq analysis, with patient probability to achieve a pCR. In particular, the expression of genes encoding for catalytic, regulatory and scaffolding subunits of PP2A will be evaluated. To correlate mutational tumor profiles, as assessed through whole-genome sequencing analysis, with patient probability to achieve a pCR.

Short-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids before and after individual FMD cycles. Long-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids assessed before consecutive FMD cycles. Eligibility Criteria. Evidence of a personally signed and dated informed consent document ICD indicating that the patient has been informed of all pertinent aspects of the study before enrollment Willingness and ability to comply with the prescribed FMD regimen, metformin intake, the scheduled visits, treatment plans, laboratory tests and other procedures.

Histologically confirmed diagnosis of invasive TNBC candidate to neoadjuvant chemotherapy and subsequent curative surgery. Female patients of childbearing potential must agree to sexual abstinence or to use two highly effective methods of contraception throughout the study and for at least six months after the end of the FMD.

Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Alternatively, two methods e.

Barrier methods must always be supplemented with the use of a spermicide. A patient is of childbearing potential if, in the opinion of the Investigator, she is biologically capable of having children and is sexually active. Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria: Prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment.

Prior treatment with anthracyclines Diagnosis of other malignancies in advanced stages unresectable, locally advanced or metastatic , or that required systemic neo adjuvant chemotherapy in the previous 5 years. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial.

History of alcohol abuse. In both cases, weight must have been stable for at least one month before study enrollment.

Active pregnancy or breast feeding. Serious infections in the previous 4 weeks before the FMD initiation, including, but not limited to, potential hospitalizations for complications of infections, bacteriemia or serious pneumonitis. Active autoimmune diseases requiring systemic treatments e. Known recent diagnosis of hypothyroidism requiring systemic replacement hormonal therapy and without stabilization of hormonal profile fT3, fT4 and TSH within the normal range.

Diagnosis of type 1 or 2 diabetes mellitus requiring pharmacologic therapy including, but not limited to, insulin, secretagogues and metformin. A diagnosis of type 2 diabetes mellitus not requiring pharmacological treatments based on the judgment of a diabetologist, is compatible with patient enrollment in the trial.

Active gastric or intestinal ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small intestine resection. Anamnesis of clinically significant heart disease including: angina pectoris, coronary bypass, symptomatic pericarditis, myocardial infarction in the previous 12 months from the beginning of experimental therapy; congestive heart failure NYHA III-IV.

Anamnesis of clinically meaningful cardiac arrhythmias, such as ventricular tachycardia, chronic atrial fibrillation, complete bundle branch block, high grade atrio-ventricular block like bi-fascicular block, type II Mobitz and third grade atrio-ventricular block, nodal arrhythmias, supra-ventricular arrhythmia. Previous episodes of symptomatic hypotension leading to loss of consciousness. Medical or psychiatric comorbidities rendering the patient not candidate to the clinical trial, according to the investigator's judgement.

Other cardiac, liver, lung or renal comorbidities, not specified in the previous inclusion or exclusion criteria, but potentially exposing the patient to a high risk of lactic acidosis. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Layout table for location contacts Contact: Claudio Vernieri, M.