Last reviewed · How we verify

NCT01131195

Metronomic Therapy in Metastatic Breast Cancer.

Completed Phase 3 Last updated 15 May 2019
What this trial tests

Phase 3 trial testing bevacizumab, Paclitaxel in Breast Cancer in 139 participants. Completed in 28 February 2018.

Timeline
19 July 2010
Primary endpoint
14 December 2012
28 February 2018

Quick facts

Lead sponsorSwiss Cancer Institute
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment139
Start date19 July 2010
Primary completion14 December 2012
Estimated completion28 February 2018
Sites23 locations across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Swiss Cancer Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bevacizumab is more effective when given together with paclitaxel or cyclophosphamide and capecitabine in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying the side effects of giving bevacizumab together with paclitaxel and to see how well it works compared with giving bevacizumab together with cyclophosphamide and capecitabine as first-line therapy in treating women with locally advanced, recurrent, or metastatic breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mouse models of advanced spontaneous metastasis for experimental therapeutics.
    Francia G, Cruz-Munoz W, Man S, Xu P, et al · · 2011 · cited 283× · PMID 21258397 · DOI 10.1038/nrc3001
  2. Metronomic oral topotecan prolongs survival and reduces liver metastasis in improved preclinical orthotopic and adjuvant therapy colon cancer models.
    Hackl C, Man S, Francia G, Milsom C, et al · · 2013 · cited 77× · PMID 22543158 · DOI 10.1136/gutjnl-2011-301585
  3. Bevacizumab and Breast Cancer: A Meta-Analysis of First-Line Phase III Studies and a Critical Reappraisal of Available Evidence.
    Rossari JR, Metzger-Filho O, Paesmans M, Saini KS, et al · · 2012 · cited 71× · PMID 23008712 · DOI 10.1155/2012/417673
  4. A model of postsurgical advanced metastatic breast cancer more accurately replicates the clinical efficacy of antiangiogenic drugs.
    Guerin E, Man S, Xu P, Kerbel RS. · · 2013 · cited 70× · PMID 23610448 · DOI 10.1158/0008-5472.can-12-4183
  5. Reappraising antiangiogenic therapy for breast cancer.
    Kerbel RS. · · 2011 · cited 50× · PMID 22015294 · DOI 10.1016/s0960-9776(11)70295-8
  6. SAKK 24/09: safety and tolerability of bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine as first-line therapy in patients with HER2-negative advanced stage breast cancer - a multicenter, randomized phase III trial.
    Rochlitz C, Bigler M, von Moos R, Bernhard J, et al · · 2016 · cited 42× · PMID 27724870 · DOI 10.1186/s12885-016-2823-y
  7. Metronomic chemotherapy and drug repurposing: A paradigm shift in oncology.
    Jan N, Sofi S, Qayoom H, Shabir A, et al · · 2024 · cited 26× · PMID 38314272 · DOI 10.1016/j.heliyon.2024.e24670
  8. Moving forward with metronomic chemotherapy: meeting report of the 2nd International Workshop on Metronomic and Anti-Angiogenic Chemotherapy in Paediatric Oncology.
    Pasquier E, Kieran MW, Sterba J, Shaked Y, et al · · 2011 · cited 25× · PMID 21804915 · DOI 10.1593/tlo.11124

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Swiss Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01131195.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing