Locally Advanced or Metastatic Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: AS1402
Product Code: AS1402
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AS1402
Other descriptive name: Therex, huHMFG1
Concentration unit: mg/ml mill
Sponsors
Antisoma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For enrolment into the study, patients must satisfy the following criteria: 1. Willing and able to provide written informed consent and in the opinion of the Investigator be able to comply with the study assessments and follow-up 2. Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative therapy 3. Measurable disease according to the RECIST criteria 4. Estrogen receptor-positive and/or progesterone receptor-positive tumour 5. Postmenopausal women defined as a. Natural menopause with last menses more than 1 year ago, or b. Radiotherapy-induced menopause with last menses more than 1 year ago, or c. Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and estradiol levels clearly in the postmenopausal range, or d. Bilateral oophorectomy 6. Performance status 0 or 1 7. Granulocyte count > 1.0 x 109/l 8. Platelet count > 100 x 109/l 9. Bilirubin 30 ml/min. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following will be excluded from the study: 1. Prior chemotherapy and/or endocrine therapy for advanced breast disease 2. Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting 3. Unknown hormonal receptor status 4. Known HER2/neu-positivity defined by either a. 3+ by immunohistochemistry, or b. HER2-positive by fluorescent in situ hybridization 5. Pregnant or nursing 6. Known HIV positivity 7. Ongoing or active infection (grade >1) 8. Psychiatric illness or social situation that would preclude study compliance 9. Other uncontrolled illness 10. History of other malignancy within the last 5 years, not including curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary efficacy endpoint: The primary efficacy endpoint is overall response rate (ORR). Secondary endpoints: - Progression-free survival (PFS) - Time to progression (TTP) - Duration of overall response and duration of stable disease - Clinical benefit rate (CBR) - Safety and tolerability of AS1402 when combined with letrozole;Main Objective: The overall objectives of this study are to compare the efficacy, safety and tolerability of AS1402 in combination with letrozole to letrozole alone as first-line treatment in post menopausal women with locally advanced or metastatic breast cancer. The primary objective is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone;Secondary Objective: • To compare the progression-free survival (PFS) of patients receiving AS1402 in combination with letrozole compared to letrozole alone • To compare the time to progression (TTP) of patients receiving AS1402 in combination with letrozole compared to letrozole alone To compare the duration of response and stable disease (per RECIST) of patients receiving AS1402 in combination with letrozole compared to letrozole alone • To compare the clinical benefit rate (CBR = PR+CR+(SD >24 weeks)) of patients receiving AS1402 in combination with letrozole compared to letrozole alone • To compare the safety in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone | — |
Countries
France, Poland
Outcome results
None listed