Phase I/II study of a new immunotherapeutic anticancer treatment administered in combination with standard therapy before surgery in patients with primary invasive breast cancer.
- Conditions
- eoadjuvant treatment of WT1-positive Stage II or III breast cancer. Patients will receive the WT1-A10 + AS15 ASCI in combination with standard neodjuvant therapy. Patients will be recruited in different cohorts according to the standard neoadjuvant treatment they will receive (aromatase inhibitor, chemotherapy or chemotherapy combined with trastuzumab).MedDRA version: 14.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-019909-42-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
1.The patient is at least 18 years of age at the time the informed consent to screening has been obtained.
2. The patient has proven T1 with lymph node involvement or T2-T4c, any N, M0 primary invasive breast cancer, histologically confirmed by core needle biopsy.
Isolated supraclavicular lymph node involvement is allowed.
3. The patient’s tumor shows WT1 antigen expression, detected by quantitative RT-PCR or any updated technique at the time of sample analysis.
4. The patient has one of the following histologically confirmed breast cancer subtypes:
•Estrogen receptor (ER) and/or progesterone (PgR) positive tumor
•HER2-overexpressing breast cancer
•HER2-negative breast cancer.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of study treatment allocation.
6. Baseline LVEF of equal or more than 50% as measured within six weeks prior to study treatment allocation by echocardiography or MUGA scan.
7. The patient shows normal organ function.
8. A female patient of childbearing potential may be enrolled in the study, if the patient:
•has practiced adequate contraception for 30 days prior to study product administration, and
•has a negative pregnancy test within one week prior to study treatment allocation, and
•has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
2. Diagnosis established by incisional biopsy.
3. Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
4. The patient is known to be human immunodeficiency virus (HIV)-positive.
5. The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
6. The patient is known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG or previous myocardial infarction or congestive heart failure.
7. The patient has a history of allergic reactions likely to be exacerbated by any component of the investigational product used in the study.
8. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
9. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
10. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the study procedures.
11. The patient has received any investigational or non-registered product (e.g., drug or vaccine) within 30 days preceding the first dose of study products or planned use during the study period.
12. The patient requires concomitant treatment with any immunosuppressive agents or with systemic corticosteroids prescribed for chronic treatment (more than seven consecutive days).
13. The patient has a significant disorder of coagulation or receives treatment with warfarin derivatives or heparin. Patients receiving individual doses of low molecular weight heparin outside of 24 hours prior to WT1-A10 + AS15 ASCI/placebo administration are eligible. Patients receiving prophylactic antiplatelet medications e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method