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

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ClinicalTrials.gov Identifier: NCT02866955
Recruitment Status : Unknown
Verified April 2017 by Institut de Cancérologie de Lorraine.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Estramustine Drug: Tamoxifen Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
GROUP E (Estramustine)
Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine
Drug: Estramustine
140mg/4 caps/day
Other Name: estramustine phosphate

GROUP T (Tamoxifen)
Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by tamoxifen
Drug: Tamoxifen
20mg/day




Primary Outcome Measures :
  1. Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing [ Time Frame: up to 6 months ]

    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 :
  1. Risks of thrombosis [ Time Frame: up to 6 months ]
    risks of thrombosis assessed by the analysis of biomarkers (D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein)

  2. Clinical benefit of estramustine [ Time Frame: 1 year ]
    clinical benefit of estramustine assessed by RECIST criteria

  3. Correlation between the answer rate and biomarkers [ Time Frame: 1 year ]
    answer rate (RECIST criteria) and level of biomarkers (Lactate déshydrogénase, Antigène carcino-embryonnaire and Cancer antigène 15-3)

  4. Tolerance of estramustine treatment [ Time Frame: 1 year ]
    Toxicity (Common Terminology Criteria for Adverse Events)

  5. Tolerance of tamoxifen treatments [ Time Frame: 1 year ]
    Toxicity (Common Terminology Criteria for Adverse Events)

  6. Proportion of patients developing thromboembolic events [ Time Frame: 1 year ]
    proportion of patients developing thromboembolic events assessed in the 2 groups every month during the one-year patient follow-up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866955


Contacts
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Contact: GILLON Veronique 0033383598608 v.gillon@nancy.unicancer.fr
Contact: FERNANDES Laurinda 0033383598487 l.fernandes@nancy.unicancer.fr

Locations
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France
Institut Sainte Catherine Recruiting
Avignon, France, 84082
Contact: Serin Daniel, MD         
CHU Besançon-Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Villanueva Christian, MD         
Polyclinique de Blois Recruiting
Blois, France, 41260
Contact: Laplaige Philippe, MD         
CHU Avicenne Recruiting
Bobigny, France, 93009
Contact: Zelek Laurent, MD         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33077
Contact: Dohollou Nadine, MD         
CHRU Brest Recruiting
Brest, France, 29200
Contact: Simon Hélène, MD         
Centre O. Lambret Recruiting
Lille, France, 59020
Contact: Bonneterre Jacques, MD         
CLCC Léon Bérard Recruiting
Lyon, France, 69373
Contact: Guastalla Jean Paul, MD         
Hôpital Privé Clairval Recruiting
Marseille, France, 13009
Contact: Robert Hervé, MD         
CHBM Site du Mittan Recruiting
Montbeliard, France, 25200
Contact: Villanueva Christian, MD         
CLCC Val d'Aurel Recruiting
Montpellier, France, 34298
Contact: Lemanski Claire, MD         
Centre Catherine de Sienne Recruiting
Nantes, France, 44202
Contact: Lortholary Alain, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Ferrero Jean Marc, MD         
CHU Tenon Recruiting
Paris, France, 75020
Contact: Gligorov Joseph, MD         
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75908
Contact: Médioni Jacques, MD         
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Eymard Jean-Christophe, MD         
Polyclinique Courlancy Reims Recruiting
Reims, France, 51100
Contact: Facchini Thomas, MD         
Clinique armoricaine Recruiting
Saint Brieuc, France, 22015
Contact: Besson Dominique, MD         
Centre Paul Strauss Recruiting
Strasbourg, France, 67000
Contact: Petit Thierry, md         
Clinique Sainte Anne Recruiting
Strasbourg, France, 67085
Contact: Dourthe Louis-Marie, MD         
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-lès-Nancy, France, 54519
Contact: Luporsi Elisabeth, MD         
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: LUPORSI Elisabeth, MD Institut de Cancérologie de Lorraine
Principal Investigator: GUASTALLA Jean Paul, MD CLCC Léon Bérard

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02866955     History of Changes
Other Study ID Numbers: 2009-017788-40
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Institut de Cancérologie de Lorraine:
aromatase inhibitors
Metastases

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estramustine
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents