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

NCT02866955 | Completed Phase 2 DMC

• 1 other identifier: 2009-017788-40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 21

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.

Conditions

Breast Cancer

Keywords

aromatase inhibitors; Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Risks of thrombosis

  up to 6 months

• Clinical benefit of estramustine

  1 year

• Correlation between the answer rate and biomarkers

  1 year

• Tolerance of estramustine treatment

  1 year

• Tolerance of tamoxifen treatments

  1 year

Study Arms (2)

GROUP E (Estramustine)

OTHER

Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine

Drug: Estramustine

GROUP T (Tamoxifen)

OTHER

Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by tamoxifen

Drug: Tamoxifen

Interventions

Estramustine DRUG

140mg/4 caps/day

Also known as: estramustine phosphate

GROUP E (Estramustine)

Tamoxifen DRUG

20mg/day

GROUP T (Tamoxifen)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Active uncontrolled infection
• Existence of an increased risk of thromboembolic event, apart from the metastatic cancer condition, such as:

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (21)

Institut Sainte Catherine

Avignon, 84082, France

Location

CHU Besançon-Jean Minjoz

Besançon, 25030, France

Location

Polyclinique de Blois

Blois, 41260, France

Location

CHU Avicenne

Bobigny, 93009, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

CHRU Brest

Brest, 29200, France

Location

Centre O. Lambret

Lille, 59020, France

Location

CLCC Léon Bérard

Lyon, 69373, France

Location

Hôpital Privé Clairval

Marseille, 13009, France

Location

CHBM Site du Mittan

Montbéliard, 25200, France

Location

CLCC Val d'Aurel

Montpellier, 34298, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Tenon

Paris, 75020, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Polyclinique Courlancy Reims

Reims, 51100, France

Location

Clinique armoricaine

Saint-Brieuc, 22015, France

Location

Centre Paul Strauss

Strasbourg, 67000, France

Location

Clinique Sainte Anne

Strasbourg, 67085, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Estramustine; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• LUPORSI Elisabeth, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• GUASTALLA Jean Paul, MD

  CLCC Léon Bérard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 15, 2016
• Study Start: June 15, 2011
• Primary Completion: August 8, 2014
• Study Completion: August 28, 2015
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)