A randomised phase II double blind (neither patient or doctor know which treatment they are taking) trial looking to see if giving patients saracatinib in addition to usual aromatase inhibitors will prevent or delay disease resistance in post menopausal women with advanced breast cancer.

Phase 1

• Conditions: Advanced breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002157-64-GB
• Lead Sponsor: Common Services Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

1. Clearly post menopausal women with ER positive (Allred score = 3) advanced breast cancer which is measurable. 2. Patients must be performance status 0 – 2. 3. Suitable for treatment with an aromatase inhibitor. 4. Life expectancy > 3 months. 5. Cancer must be HER2- (by FISH and/or IHC as appropriate), OR if the cancer is HER2+ the patient must not be a candidate for ant-HER2 therapy. 6. All patients will need to also meet inclusion criteria for one of the two main strata (noting that entry of patients in sratum (b) is limited to those who DON'T qualify for strata (a): a. AI-sensitive/naive” group – either never previously treated with an aromatase inhibitor, but if treated with tamoxifen must not have rapid progression on tamoxifen (i.e. treated for at least 24 months adjuvant or = 6 months in metastatic setting); or, if previously treated with an AI, only in the adjuvant or neo-adjuvant setting AND have remained free of progression for at least 12 months whilst not being treated with an AI. b. prior AI” group – previously treated with a non-steroidal AI without progression for at least 24 months in the (neo-) adjuvant setting or for at least 6 months for advanced disease. 7. Patients who have had two lines of prior AI therapy will not be eligible UNLESS they were switched from one AI to another ONLY for reasons of toxicity, and ONLY during (neo-) adjuvant therapy AND in the absence of any evidence of progression/relapse. 8. Single site of bone disease must be histologically confirmed and known not to be ER negative. 9. Palliative radiotherapy can be given to bone lesions within 4 weeks of trial entry provided not more than 20% of the bone marrow is irradiated, AND there is at least one other measurable bone lesion which has clearly progressed since any prior irradiation. 10. Haematology – commensurate with a phase II hormonal therapy study: Neutrophils > 1.5 * 109/l, Hb> 10.0 g/dl and Platelets > 100 * 109/l 11. Biochemistry – similar: albumin normal, ALT/AST < 2.5 ULN, Alk Phos < 5 * ULN unless of bone origin, e-GFR > 50ml/min. Normal urea & electrolytes. 12. Patients receiving bisphosphonates are eligible, provided they are commenced before, or at, trial entry. Patients will be stratified by use of, or stated intention to give, bisphosphonate at randomisation. Some patients will already be on bisphosphonates, but eg for those newly diagnosed with bone metastases, first administration of the bisphosphonate is encouraged to be given prior to entry (but after baseline blood and urine), but in any case, must be started no less than 1 week AFTER first study medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Patients with short life expectancy or significant other co-morbidity including pulmonary fibrosis will be excluded 2. Rapidly progressive visceral disease (lymphangitis, diffuse liver disease, uncontrolled CNS disease). 3. Any evidence of severe or uncontrolled systemic conditions (e.g. interstitial lung disease [bilateral, diffuse, parenchymal change]) 4. Life expectancy < 3 months. 5. Contra-indication to either AZD0530 (or excipients) or aromatase inhibition. 6. Concomitant chemotherapy or anti-HER2 therapy. 7. Measured QTc > 480ms.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified