Status:
TERMINATED
Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer. The treatm...
Detailed Description
The study will be conducted in two consecutive segments (Phase I and Phase II), each with specific objectives. Active follow-up will be for three years. Patients in this study will be allocated to co...
Eligibility Criteria
Inclusion
- The patient is ≥ 18 years of age at the time the informed consent to screening has been obtained.
- 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.
- The patient's tumor shows WT1 antigen expression.
- The patient has one of the following histologically confirmed breast cancer subtypes:
- Estrogen receptor and/or progesterone positive tumor.
- Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.
- HER2-negative breast cancer.
- Eastern Cooperative Oncology Group (performance status of 0 or 1 at the time of study treatment allocation.
- Baseline left ventricular ejection fraction of ≥ 50% as measured within six weeks prior to study treatment allocation by echocardiography or multi-gated acquisition(MUGA)scan.
- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation)::
- Hemoglobin: Within normal range according to institutional standards.
- Absolute leukocyte count: Within normal range according to institutional standards.
- Absolute lymphocyte count: Within normal range according to institutional standards.
- Platelet count: Within normal range according to institutional standards
- Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN)
- Aspartate aminotransferase: ≤ 2.5 x ULN
- Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN
- Serum creatinine: 1.5 x ULN
- Calculated creatinine clearance: \> 50 mL/min
- 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 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.In view of the investigator, the patient can and will comply with the requirements of the protocol.
- Written informed consent has been obtained from the patient prior to performance of any study specific procedure.
Exclusion
- The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion.
- Diagnosis established by incisional biopsy.
- 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.
- The patient is known to be human immunodeficiency virus -positive.
- 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.
- 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 electrocardiogram or previous myocardial infarction or congestive heart failure.
- The patient has a history of allergic reactions likely to be exacerbated by any component of the investigational product used in the study.
- 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.
- 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.
- The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the study procedures.
- The patient has received any investigational or non-registered product within 30 days preceding the first dose of study products or planned use during the study period.
- The patient requires concomitant treatment with any immunosuppressive agents or with systemic corticosteroids prescribed for chronic treatment.
- 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.
Key Trial Info
Start Date :
April 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01220128
Start Date
April 11 2011
End Date
November 14 2014
Last Update
May 25 2021
Active Locations (36)
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1
GSK Investigational Site
Newark, Delaware, United States, 19713
2
GSK Investigational Site
Plantation, Florida, United States, 33324
3
GSK Investigational Site
Boston, Massachusetts, United States, 02114
4
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5848