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

Breast Cancer Clinical Trial

— EFESE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866955
• Other study ID #: 2009-017788-40
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2011
• Est. completion date: August 28, 2015

Study information

• Verified date: March 2020
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 28, 2015
• Est. primary completion date: August 8, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Estramustine
140mg/4 caps/day
• Tamoxifen
20mg/day

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	CHU Besançon-Jean Minjoz	Besançon
France	Polyclinique de Blois	Blois
France	CHU Avicenne	Bobigny
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	CHRU Brest	Brest
France	Centre O. Lambret	Lille
France	CLCC Léon Bérard	Lyon
France	Hôpital Privé Clairval	Marseille
France	CHBM Site du Mittan	Montbeliard
France	CLCC Val d'Aurel	Montpellier
France	Centre Catherine de Sienne	Nantes
France	Centre Antoine Lacassagne	Nice
France	CHU Tenon	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Jean Godinot	Reims
France	Polyclinique Courlancy Reims	Reims
France	Clinique armoricaine	Saint Brieuc
France	Centre Paul Strauss	Strasbourg
France	Clinique Sainte Anne	Strasbourg
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing	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	up to 6 months
Secondary	Risks of thrombosis	risks of thrombosis assessed by the analysis of biomarkers (D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein)	up to 6 months
Secondary	Clinical benefit of estramustine	clinical benefit of estramustine assessed by RECIST criteria	1 year
Secondary	Correlation between the answer rate and biomarkers	answer rate (RECIST criteria) and level of biomarkers (Lactate déshydrogénase, Antigène carcino-embryonnaire and Cancer antigène 15-3)	1 year
Secondary	Tolerance of estramustine treatment	Toxicity (Common Terminology Criteria for Adverse Events)	1 year
Secondary	Tolerance of tamoxifen treatments	Toxicity (Common Terminology Criteria for Adverse Events)	1 year
Secondary	Proportion of patients developing thromboembolic events	proportion of patients developing thromboembolic events assessed in the 2 groups every month during the one-year patient follow-up	1 year