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NCT01525589

A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer

Study identifier: NCT01525589
Full study details on clinicaltrials.gov

Name of investigational agent used in study:

PM01183 (PharmaMar)

Eligibility:

Inclusion Criteria:

  • Proven diagnosis of metastatic breast cancer (MBC)
  • At least one, but no more than three, prior chemotherapy regimens for MBC.
  • At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and at least one week since the last hormonal therapy and at least two weeks since the last biological/investigational therapy
  • Known deleterious germline mutation of BRCA1/2 (hereditary breast cancer)
  • Patients with only bone metastasis are not eligible
  • Patients with symptomatic or progressive brain metastases are not eligible

Type of study:

Phase II study

Treatment:

Patients will receive one of two strengths of PM01183:

  • 1 mg/vial
  • 4 mg/vial

administration by injection every three weeks

Study sites:

Massachusetts
Boston
Massachusetts General Hospital
Contact: Steven Jay Isakoff, M.D. 617-726-4920 SISAKOFF@PARTNERS.ORG


Page updated 06/19/13

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