PubTransformer

A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

SAFE trial: an ongoing randomized clinical study to assess the role of cardiotoxicity prevention in breast cancer patients treated with anthracyclines with or without trastuzumab.

Abstract Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies. Even though the cardiology and oncology community strongly recommend a cardiotoxicity prevention strategy for this subset of patients, there is still no consensus on the optimal patient's approach. We aimed to review the published and ongoing researches on cardioprevention strategies and to present the SAFE trial (CT registry ID: NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effect of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast cancer patients.
PMID
Related Publications

Evaluation and management of chemotherapy-induced cardiotoxicity in breast cancer: a Delphi study.

Toxicity of dual HER2-blockade with pertuzumab added to anthracycline versus non-anthracycline containing chemotherapy as neoadjuvant treatment in HER2-positive breast cancer: The TRAIN-2 study.

Is it safe to give anthracyclines concurrently with trastuzumab in neo-adjuvant or metastatic settings for HER2-positive breast cancer? A meta-analysis of randomized controlled trials.

Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101--Breast): a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI.

Anthracycline-trastuzumab regimens for HER2/neu-overexpressing breast cancer: current experience and future strategies.

Authors

Mayor MeshTerms
Keywords

Adjuvant anthracyclines

Beta-blockers

Breast cancer

Cardiotoxicity prevention

Trastuzumab

Journal Title medical oncology (northwood, london, england)
Publication Year Start




PMID- 28364270
OWN - NLM
STAT- MEDLINE
DA  - 20170401
DCOM- 20170419
LR  - 20170419
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 34
IP  - 5
DP  - 2017 May
TI  - SAFE trial: an ongoing randomized clinical study to assess the role of
      cardiotoxicity prevention in breast cancer patients treated with anthracyclines
      with or without trastuzumab.
PG  - 75
LID - 10.1007/s12032-017-0938-x [doi]
AB  - Over the years, thanks to the addition of new generation systemic agents, as well
      as the use of more advanced and precise radiotherapy techniques, it was able to
      obtain a high curability rate for breast cancer. Anthracyclines play a key role
      in the treatment of breast disease, with a well-known benefit on disease-free
      survival of patients with positive nodal status. Trastuzumab have shown a
      significant outcome advantage after 1-year administration in case of
      HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has 
      been observed after anthracyclines and trastuzumab therapies. Even though the
      cardiology and oncology community strongly recommend a cardiotoxicity prevention 
      strategy for this subset of patients, there is still no consensus on the optimal 
      patient's approach. We aimed to review the published and ongoing researches on
      cardioprevention strategies and to present the SAFE trial (CT registry ID:
      NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3,
      four-arm, single-blind, placebo-controlled study that aims to evaluate the effect
      of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart 
      damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast 
      cancer patients.
FAU - Meattini, Icro
AU  - Meattini I
AUID- ORCID: http://orcid.org/0000-0002-1861-2895
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy. [email protected]
FAU - Curigliano, Giuseppe
AU  - Curigliano G
AD  - Early Drug Development for Innovative Therapies Division, European Institute of
      Oncology, Milan, Italy.
FAU - Terziani, Francesca
AU  - Terziani F
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Becherini, Carlotta
AU  - Becherini C
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Airoldi, Mario
AU  - Airoldi M
AD  - Breast Unit, Azienda Ospedaliero Universitaria Citta della Salute e della
      Scienza, Turin, Italy.
FAU - Allegrini, Giacomo
AU  - Allegrini G
AD  - Medical Oncology Unit, Presidio Ospedaliero Felice Lotti, Pontedera, Italy.
FAU - Amoroso, Domenico
AU  - Amoroso D
AD  - UOC di Oncologia, Ospedale Versilia, Istituto Toscano Tumori, Lido di Camaiore,
      Italy.
FAU - Barni, Sandro
AU  - Barni S
AD  - Dipartimento Oncologico ASST - Bergamo Ovest, Treviglio, Italy.
FAU - Bengala, Carmelo
AU  - Bengala C
AD  - Medical Oncology Unit, Ospedale Misericordia, Grosseto, Italy.
FAU - Guarneri, Valentina
AU  - Guarneri V
AD  - Division of Medical Oncology 2, Istituto Oncologico Veneto, Padua, Italy.
FAU - Marchetti, Paolo
AU  - Marchetti P
AD  - Medical Oncology Unit, Azienda Ospedaliera Sant'Andrea, Rome, Italy.
FAU - Martella, Francesca
AU  - Martella F
AD  - Breast Unit, Santa Maria Annunziata Hospital, Florence, Italy.
FAU - Piovano, Pierluigi
AU  - Piovano P
AD  - SC Oncologia, Ospedale Ss. Antonio e Biagio e C. Arrigo, Alessandria, Italy.
FAU - Vannini, Agnese
AU  - Vannini A
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Desideri, Isacco
AU  - Desideri I
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Tarquini, Roberto
AU  - Tarquini R
AD  - Medicina Interna 1, Ospedale San Giuseppe, Empoli, Italy.
FAU - Galanti, Giorgio
AU  - Galanti G
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Barletta, Giuseppe
AU  - Barletta G
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
FAU - Livi, Lorenzo
AU  - Livi L
AD  - Azienda Ospedaliero Universitaria Careggi - University of Florence, Largo G.A.
      Brambilla 3, 50134, Florence, Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20170331
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - 0 (Anthracyclines)
RN  - 0 (Cardiotonic Agents)
RN  - L35JN3I7SJ (Ramipril)
RN  - P188ANX8CK (Trastuzumab)
RN  - Y41JS2NL6U (Bisoprolol)
SB  - IM
MH  - Anthracyclines/*adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use
MH  - Bisoprolol/therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Cardiotonic Agents/*therapeutic use
MH  - Cardiotoxicity/*prevention & control
MH  - Clinical Trials, Phase III as Topic
MH  - Female
MH  - Humans
MH  - Ramipril/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Trastuzumab/administration & dosage/*adverse effects
OTO - NOTNLM
OT  - *Adjuvant anthracyclines
OT  - *Beta-blockers
OT  - *Breast cancer
OT  - *Cardiotoxicity prevention
OT  - *Trastuzumab
EDAT- 2017/04/02 06:00
MHDA- 2017/04/20 06:00
CRDT- 2017/04/02 06:00
PHST- 2017/02/17 [received]
PHST- 2017/03/28 [accepted]
AID - 10.1007/s12032-017-0938-x [doi]
AID - 10.1007/s12032-017-0938-x [pii]
PST - ppublish
SO  - Med Oncol. 2017 May;34(5):75. doi: 10.1007/s12032-017-0938-x. Epub 2017 Mar 31.

<?xml version="1.0" encoding="UTF-8"?>
<b:Sources SelectedStyle="" xmlns:b="http://schemas.openxmlformats.org/officeDocument/2006/bibliography"  xmlns="http://schemas.openxmlformats.org/officeDocument/2006/bibliography" >
</b:Sources>