A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination with Letrozole as First Line Treatment in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001806-17-PL
• Date of registration: 14/11/2008
• Prospective Registration: Yes
• Primary sponsor: Antisoma Research Limited
• Public title: A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination with Letrozole as First Line Treatment in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer.
• Scientific title: A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination with Letrozole as First Line Treatment in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer.
• Date of first enrolment: 28/01/2009
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001806-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Poland

Key inclusion & exclusion 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 10^9/l
8. Platelet count > 100 x 10^9/l
9. Bilirubin < 2 times the upper limit of normal (ULN)
10. AST and/or ALT < 5 times ULN
11. Creatinine Clearance > 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Locally Advanced or Metastatic Breast Cancer
MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer

Intervention(s)

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 milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: letrozole
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809515
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

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

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

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

Secondary ID(s)

AS1402-C-201

2008-001806-17-FR