EUCTR2014-004112-11-GB
Active, not recruiting
Phase 1
ALERT: A phase II study of alternating eribulin and hormonal therapy in pre-treated ER+ve breast cancer - ALERT
ConditionsPatients with locally advanced or metastatic oestrogen receptor positive (ER+ve) breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting.MedDRA version: 18.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHalaven
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with locally advanced or metastatic oestrogen receptor positive (ER+ve) breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting.
- Sponsor
- Imperial College London
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent prior to admission to this study
- •2\. Aged 18\=over
- •3\. Histologically confirmed ER positive metastatic breast cancer according to
- •local criteria.
- •4\. ECOG performance status 0 – 2
- •5\. Have progressed after at least one hormonal therapy regime and at least one
- •chemotherapy regime for advanced disease
- •6\. Patients must have had prior treatment with an anthracycline and a taxane
- •(either sequential or in combination) unless patients weren’t suitable for
- •these treatments. This treatment can be in the adjuvant setting
Exclusion Criteria
- •1\. Triple negative or HER2 positive cancer
- •2\. Hypersensitivity to the active substance or to any of its excipients
- •3\. History of another primary malignancy within 5 years prior to starting study
- •treatment, except adequately treated basal or squamous cell carcinoma of the
- •skin, carcinoma in site and the disease under study
- •4\. Evidence of uncontrolled active infection
- •5\. Severe hepatic impairment (Child\-Pugh C)
- •6\. Evidence of significant medical condition or laboratory finding which, in the
- •opinion of the Investigator, makes it undesirable for the patient to
- •participate in the trial
Outcomes
Primary Outcomes
Not specified
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