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Clinical Trial
. 2014 Feb 5:14:66.
doi: 10.1186/1471-2407-14-66.

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

Peter A Fasching  1 , Sebastian M Jud, Maik Hauschild, Sherko Kümmel, Martin Schütte, Matthias Warm, Volker Hanf, Dieter Grab, Jutta Krocker, Elmar Stickeler, Rolf Kreienberg, Thomas Müller, Thorsten Kühn, Christopher Wolf, Steffen Kahlert, Stefan Paepke, Michael Berghorn, Mathias Muth, Monika Baier, Birgit Wackwitz, Rüdiger Schulz-Wendtland, Matthias W Beckmann, Michael P Lux
Affiliations
Clinical Trial

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

Peter A Fasching et al. BMC Cancer. .

Abstract

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.

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Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) diagram. ITT, intention to treat; mITT, modified intention to treat; LET, letrozole alone; LET + ZOL, letrozole plus zoledronic acid.
Figure 2
Figure 2
Primary efficacy analysis: Response Evaluation Criteria in Solid Tumors (RECIST) tumor response rates (complete response + partial response) at month 6, based on the central review (modified intention to treat, last observation carried forward).
See this image and copyright information in PMC

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