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Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Neoplasms, Breast

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Trial Information

Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

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.

The protocol has been updated following Protocol Amendment 3, July 2012, leading to the
update of the inclusion criteria.

Inclusion Criteria:

1. The patient is >= 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.

4. 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.

5. Eastern Cooperative Oncology Group (performance status of 0 or 1 at the time of

- Baseline left ventricular ejection fraction of >= 50% as measured within four
weeks prior to randomization by echocardiography or multi-gated acquisition

6. The patient shows normal organ function according to the following parameters:

- Hemoglobin: Within normal range according to institutional standards

- Absolute leukocyte count: Within normal range according to institutional

- Absolute lymphocyte count: Within normal range according to institutional

- 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

- Serum creatinine: 1.5 x ULN

- Calculated creatinine clearance: > 50 mL/min

7. A female patient of childbearing potential may be enrolled in the study, if the

- has practiced adequate contraception for 30 days prior to study product
administration, and

- has a negative pregnancy test on the day of administration, and

- has agreed to continue adequate contraception during the entire treatment period
and for 2 months after completion of the study product administration series.

8. In view of the investigator, the patient can and will comply with the requirements of
the protocol.

9. Written informed consent has been obtained from the patient prior to performance of
any study specific procedure.

Exclusion Criteria:

1. The patient has inflammatory breast cancer, which is defined as clinically
significant erythema of the breast and/or documented dermal lymphatic invasion.

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 -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

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 electrocardiogram 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 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. .

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Phase I segment of the study: occurrence of severe toxicities.

Outcome Time Frame:

On a continuous basis during the whole study duration (Day 0 to 36 months after concluding visit-30 days post-surgery).

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Italy: Isituto Superiore di Sanita'

Study ID:




Start Date:

April 2011

Completion Date:

November 2022

Related Keywords:

  • Neoplasms, Breast
  • WT1
  • neoadjuvant
  • tumor antigen
  • immunotherapy
  • breast cancer
  • adult
  • Breast Neoplasms
  • Neoplasms



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