Clinical Trials /

Efficacy and Safety of Estracyt® in Metastatic Breast Cancer

NCT02853071

Description:

This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
  • Official Title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.

Clinical Trial IDs

  • ORG STUDY ID: P/2015/269
  • NCT ID: NCT02853071

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Estramustineestracyt, estramustine phosphateEstramustine
standard practiceStandard practice center

Purpose

This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

Detailed Description

      For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is
      hormonotherapy. But, when patients don't react no recommendations exist.

      Estramustine phosphate is currently prescribed for prostate cancer. The estramustine
      phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard
      with the estradiol, it settles on membrane receptor and the cytotoxic component acts
      essentially by dismantling microtubules inhibiting the mitosis.

      Estramustine could be a therapeutic option when currently therapy are exhausted for patients
      reactive to hormonotherapy previous lines or chemotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
EstramustineExperimental560 mg per day
  • Estramustine
Standard practice centerActive ComparatorStandard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin
  • standard practice

Eligibility Criteria

        Inclusion Criteria:

          -  Metastatic breast cancer HER2-/RH+

          -  Progression after hormonotherapy

          -  Treated by taxanes, anthracyclines, capecitabine and eribulin

          -  Treated by everolimus

          -  ECOG ≤ 2

          -  Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥
             100 x 109 / L

          -  Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of
             the standard) (unless disease of Gilbert), transaminases ≥ 3 x N

          -  Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL
             / min

          -  Estimated Life expectancy ≥ 3 months

        Exclusion Criteria:

          -  Hypersensitivity known about one of the constituents of the estramustine phosphates

          -  Preliminary Treatment by estramustine phosphates

          -  Brain Metastases

          -  Patients not being under effective contraception

          -  Minor, pregnant or lactating Patients

          -  Patients not previously treated by everolimus

          -  Transaminases > 3xN

          -  Other concomitant anticancer treatment less than 1 month before the inclusion

          -  Digestive function: malabsorption

          -  History of other cancer in the previous 5 years (other than squamous-cell epithelioma
             or totally resected in situ carcinoma)

          -  Active Thrombo-phlebitis

          -  Risk thromboembolic known,

          -  Unchecked cardiovascular Pathology

          -  Grave hepatic Affection
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of the alive patients without progress of the disease
Time Frame:3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:quality of life
Time Frame:18 months
Safety Issue:
Description:European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
Measure:progression-free survival
Time Frame:18 months
Safety Issue:
Description:
Measure:overall survival
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Centre Hospitalier Universitaire de Besancon

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