Advanced breast cancer
Conditions
Interventions
Product Name: Saracatinib
Product Code: AZD0530
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Saracatinib
Current Sponsor
Sponsors
Common Services Agency
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 480ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary research objective is to see whether patients taking an aromatase inhibitor in combination with saracatinib have a longer progression free survival (surving without their cancer growing or spreading) than the patients who are taking aromatase inhibitor with placebo.;Secondary Objective: Secondary objectives are: - To see if there are more side effects from taking an aromatase inhibitor and saracatinib compared to taking an aromatase inhibitor alone and to see how severe any side effects are. - To compare overall survival length for both sets of patients. - To test how well tumours shrink/respond to drug treatment, using regular scans/images of the cancer.;Primary end point(s): Comparison of progression free survival between cohort receiving aromatase inhibition plus saracatinib, versus those receiving aromatase inhibition plus placebo.;Timepoint(s) of evaluation of this end point: after 110 progression events have occured and at least 6 months after last patient has enrolled (whichever is the later of these two circumstances) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity, tumour shrinkage and overall survival. Translational sub-studies also planned.;Timepoint(s) of evaluation of this end point: secondary end-points with the primary, except for overall survival which will be analysed using data up to 31st March 2017, and the translational ones the timing of which will depend on when the lab studies are complete | — |
Countries
United Kingdom
Contacts
Public ContactEve Macdonald
NHS National Service Scotland
Outcome results
None listed