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.
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
Interventions
Drug | Synonyms | Arms |
---|
Estramustine | estramustine phosphate | GROUP E (Estramustine) |
Tamoxifen | | GROUP 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
Name | Type | Description | Interventions |
---|
GROUP E (Estramustine) | Other | Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine | |
GROUP T (Tamoxifen) | Other | Patients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by 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: | Completed |
Lead Sponsor: | Institut de Cancérologie de Lorraine |
Trial Keywords
- aromatase inhibitors
- Metastases
Last Updated
March 9, 2020