Clinical Trials /

Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.

NCT02866955

Description:

Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis. Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer. Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation. This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.
  • Official Title:

Clinical Trial IDs

  • ORG STUDY ID: 2009-017788-40
  • NCT ID: NCT02866955

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Estramustineestramustine phosphateGROUP E (Estramustine)
TamoxifenGROUP T (Tamoxifen)

Purpose

Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis. Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer. Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation. This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

Trial Arms

NameTypeDescriptionInterventions
GROUP E (Estramustine)OtherPatients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine
  • Estramustine
GROUP T (Tamoxifen)OtherPatients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by tamoxifen
  • Tamoxifen

Eligibility Criteria

        Inclusion Criteria:

          -  Post-menopausal women or women receiving Luteinizing hormone-releasing hormone (LHRH)
             analogs

          -  Histologically confirmed metastatic breast cancer RH+

          -  Measurable metastatic breast cancer (modified RECIST criteria) or not measurable but
             evaluable

          -  Recurrence:

               -  being treated with aromatase inhibitors (AIs)

               -  after adjuvant treatment by AIs

               -  after progression of the metastatic cancer in patients receiving AIs following
                  positive response during at least 6 months

          -  Performance status ≤ 2

          -  Haematological test: polynuclear neutrophiles ≥ 1.5 × 109 /L, haemoglobin ≥ 9 g/dL,
             blood platelet ≥ 100 × 109 /L

          -  Hepatic function: albumin ≥ 2.5 g/dL, serum bilirubin ≤ 1.5 × N (except if Gilbert's
             Syndrome) , aminotransferases ≤ 3 × N (≤ 5 × N if hepatic metastases)

          -  Renal function: serum creatinine ≤ 1.5 mg/dL or clearance of creatinine ≥ 40 ml/min

          -  Women without endometrial pathology

          -  Ability to provide written informed consent before the start of any study specific
             procedures

        Exclusion Criteria:

          -  Age < 18 years old

          -  Pre-menopausal, pregnant or pregnant or breast feeding females

          -  Patient who should exclusively be treated by chemotherapy

          -  Women previously treated with chemotherapy but not by AIs

          -  Women previously treated by tamoxifen for their metastatic breast cancer

          -  HER2+

          -  Concurrent anti-cancer treatment (chemotherapy, surgery, immunotherapy, biological
             therapy and tumour embolism)

          -  Concurrent treatment with protocol-defined prohibited medications

          -  Malabsorption syndrome , significant digestive dysfunction, gastrectomy, jejunectomy,
             hemorrhagic recto colon

          -  Concurrent disease or condition that may interfere with study participation, or any
             serious medical disorder that would interfere with the subject's safety (for example,
             active or uncontrolled infection or any psychiatric condition prohibiting
             understanding or rendering of informed consent)

          -  Any pathology, including severe psychiatric or psychologic disease that may harm
             patient's safety or participation in the study

          -  Serious or not cured or unstable toxicity due to the administration of another drug
             being involved in clinical trials

          -  Uncontrolled cardiovascular pathologies

          -  Previous history of thromboembolic event like deep vein thrombosis or pulmonary
             embolism recorded within one year before the inclusion date

          -  Active uncontrolled infection

          -  Existence of an increased risk of thromboembolic event, apart from the metastatic
             cancer condition, such as:

               -  known presence of antiphospholipid antibody

               -  family history of thrombophilia

               -  existence of any clinical, genetic, or biological abnormality which can increase
                  the risk of thromboembolic event according to the

          -  Participation to a clinical trial at least 4 weeks prior the start of the study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing
Time Frame:up to 6 months
Safety Issue:
Description:proportion of patients in progression-free survival (PFS) after a 6-month treatment is defined as the duration of objective response or stabilisation of the disease according to the Recist criteria. The following events shall be considered as progressive : Relapse Treatment intolerance leading to stop the treatment Death

Secondary Outcome Measures

Measure:Risks of thrombosis
Time Frame:up to 6 months
Safety Issue:
Description:risks of thrombosis assessed by the analysis of biomarkers (D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein)
Measure:Clinical benefit of estramustine
Time Frame:1 year
Safety Issue:
Description:clinical benefit of estramustine assessed by RECIST criteria
Measure:Correlation between the answer rate and biomarkers
Time Frame:1 year
Safety Issue:
Description:answer rate (RECIST criteria) and level of biomarkers (Lactate déshydrogénase, Antigène carcino-embryonnaire and Cancer antigène 15-3)
Measure:Tolerance of estramustine treatment
Time Frame:1 year
Safety Issue:
Description:Toxicity (Common Terminology Criteria for Adverse Events)
Measure:Tolerance of tamoxifen treatments
Time Frame:1 year
Safety Issue:
Description:Toxicity (Common Terminology Criteria for Adverse Events)
Measure:Proportion of patients developing thromboembolic events
Time Frame:1 year
Safety Issue:
Description:proportion of patients developing thromboembolic events assessed in the 2 groups every month during the one-year patient follow-up

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Institut de Cancérologie de Lorraine

Trial Keywords

  • aromatase inhibitors
  • Metastases

Last Updated