EUCTR2011-005680-25-GB
Active, not recruiting
Phase 1
A Phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER positive locally advanced or metastatic breast cancer patients. - IRIS v1.0
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imperial College London
- Enrollment
- 28
- 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 \= 25 years of age.
- •3\. Histologically confirmed ER\+ve primary or metastatic breast cancer according to local criteria.
- •4\. Locally advanced1 or metastatic breast cancer treated with 1st line AI treatment with either:
- •A documented objective response (CR/PR) at any point after beginning on a 1st line AI prior to disease progression.
- •Disease stabilisation (SD) for at least 6 months on a 1st line AI prior to disease progression.
- •5\. Postmenopausal as defined by any of the following criteria:
- •a. Amenorrhoea for at least 6 months prior to study entry and estradiol and LH/FSH in the postmenopausal range on local laboratory analysis whilst taking a 3rd genera\-tion AI during the screening phase of the study.
- •b. Amenorrhoea during combination treatment with ovarian suppression (e.g. goserelin) and an AI in which case estradiol should be below the limit of de\-tection of the standard local laboratory assay during the screening phase of the study.
- •6\. ECOG performance status 0 to 2\.
Exclusion Criteria
- •1\. HER2 positive cancer.
- •2\. Discontinuation of current AI therapy for \> 21 days prior to study entry\*.
- •3\. Rapidly progressive, life\-threatening metastases, including any of the following:
- •a) Patients with active parenchymal brain or leptomeningeal involvement
- •b) Symptomatic lymphangitis carcinomatosis
- •c) Extensive visceral metastases requiring chemotherapy.
- •4\. Patients with a 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.
- •5\. More than one prior line of chemotherapy for locally advanced or metastatic disease.
- •6\. AI therapy given in combination with another endocrine agent with the exception of a GnRH agonist.
- •7\. Radiotherapy to measurable lesion within 2 months of treatment start.
Outcomes
Primary Outcomes
Not specified
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