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

Institut de Cancérologie de Lorraine

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Estramustine

Drug: Tamoxifen

Study type

Interventional

Funder types

Other

Identifiers

NCT02866955

2009-017788-40

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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