PMID- 24499441
OWN - NLM
STAT- MEDLINE
DCOM- 20141030
LR  - 20240321
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 14
DP  - 2014 Feb 5
TI  - FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and 
      zoledronic acid with letrozole in primary breast cancer patients.
PG  - 66
LID - 10.1186/1471-2407-14-66 [doi]
AB  - BACKGROUND: The objective of this prospectively randomized phase II trial (Trial 
      registration: EUCTR2004-004007-37-DE) was to compare the clinical response of 
      primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) 
      or letrozole and zoledronic acid (LET + ZOL). METHODS: Patients were randomly 
      assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 
      mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 
      months. Primary endpoint was clinical response rate as assessed by mammogram 
      readings. The study was terminated prematurely due to insufficient recruitment. 
      We report here on an exploratory analysis of this data. RESULTS: Central 
      assessment of tumor sizes during the treatment period was available for 131 
      patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were 
      seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% 
      CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model 
      showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. CONCLUSION: No 
      increase in the clinical response rate was observed with the addition of ZOL to a 
      neoadjuvant treatment regimen with LET. However a trend towards a better reponse 
      in the LET + ZOL arm could be observed. This trend is consistent with previous 
      studies that have investigated the addition of ZOL to chemotherapy, and it may 
      support the evidence for a direct antitumor action of zoledronic acid.
FAU - Fasching, Peter A
AU  - Fasching PA
AD  - University Breast Center, Department of Gynecology and Obstetrics, Erlangen 
      University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, 
      Erlangen Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. 
      peter.fasching@uk-erlangen.de.
FAU - Jud, Sebastian M
AU  - Jud SM
FAU - Hauschild, Maik
AU  - Hauschild M
FAU - Kummel, Sherko
AU  - Kummel S
FAU - Schutte, Martin
AU  - Schutte M
FAU - Warm, Matthias
AU  - Warm M
FAU - Hanf, Volker
AU  - Hanf V
FAU - Grab, Dieter
AU  - Grab D
FAU - Krocker, Jutta
AU  - Krocker J
FAU - Stickeler, Elmar
AU  - Stickeler E
FAU - Kreienberg, Rolf
AU  - Kreienberg R
FAU - Muller, Thomas
AU  - Muller T
FAU - Kuhn, Thorsten
AU  - Kuhn T
FAU - Wolf, Christopher
AU  - Wolf C
FAU - Kahlert, Steffen
AU  - Kahlert S
FAU - Paepke, Stefan
AU  - Paepke S
FAU - Berghorn, Michael
AU  - Berghorn M
FAU - Muth, Mathias
AU  - Muth M
FAU - Baier, Monika
AU  - Baier M
FAU - Wackwitz, Birgit
AU  - Wackwitz B
FAU - Schulz-Wendtland, Rudiger
AU  - Schulz-Wendtland R
FAU - Beckmann, Matthias W
AU  - Beckmann MW
FAU - Lux, Michael P
AU  - Lux MP
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20140205
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Diphosphonates)
RN  - 0 (Imidazoles)
RN  - 0 (Nitriles)
RN  - 0 (Triazoles)
RN  - 6XC1PAD3KF (Zoledronic Acid)
RN  - 7LKK855W8I (Letrozole)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
MH  - Breast Neoplasms/*diagnosis/*drug therapy/epidemiology
MH  - Diphosphonates/administration & dosage
MH  - Female
MH  - Humans
MH  - Imidazoles/administration & dosage
MH  - Letrozole
MH  - Middle Aged
MH  - Neoadjuvant Therapy/*methods
MH  - Nitriles/*administration & dosage
MH  - Prospective Studies
MH  - Triazoles/*administration & dosage
MH  - Zoledronic Acid
PMC - PMC3937056
EDAT- 2014/02/07 06:00
MHDA- 2014/10/31 06:00
PMCR- 2014/02/05
CRDT- 2014/02/07 06:00
PHST- 2013/03/14 00:00 [received]
PHST- 2014/01/31 00:00 [accepted]
PHST- 2014/02/07 06:00 [entrez]
PHST- 2014/02/07 06:00 [pubmed]
PHST- 2014/10/31 06:00 [medline]
PHST- 2014/02/05 00:00 [pmc-release]
AID - 1471-2407-14-66 [pii]
AID - 10.1186/1471-2407-14-66 [doi]
PST - epublish
SO  - BMC Cancer. 2014 Feb 5;14:66. doi: 10.1186/1471-2407-14-66.