Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

NCT01220128 | Terminated Phase 2 Results

• 2 other identifiers: 1131722010-019909-42
• Study Type: interventional
• Target: 66
• Locations: 7 countries
• Sites: 36

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 treatment will be given before surgery in combination with standard therapy.

Conditions

Neoplasms, Breast

Keywords

WT1; neoadjuvant; tumor antigen; immunotherapy; breast cancer; adult

Outcome Measures

Primary Outcomes (28)

• Number of Subjects With Severe Toxicities

  Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at \< 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo. - A Grade 2 or higher allergic reaction occurring within 24 hours following the administration. - A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration. - A decrease in renal function at the time of administration that was considered as related or possibly related.

  From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

• Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response

  For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-administration antibody concentration.

  At post-GSK2302024A/placebo Dose 4 (Week 13)

• Number of Patients With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Serious Adverse Events SAE(s)

  A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.

  From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

• Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Anemia, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and post 30 days post last administration

• Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported

  Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

  During the treatment period and up to 30 days post last administration

• Number of Subjects With Breast Cancer Pathological Response

  The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.

  During the treatment period, up to Week 26/32

Study Arms (7)

Cohort A-GSK2302024A Group

EXPERIMENTAL

This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.

Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A; Drug: Aromatase inhibitor

Cohort A-Placebo Group

PLACEBO COMPARATOR

This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.

Drug: Placebo; Drug: Aromatase inhibitor; Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel

Cohort B-GSK2302024A Group

EXPERIMENTAL

This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.

Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A; Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel

Cohort B-Placebo Group

PLACEBO COMPARATOR

This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.

Drug: Placebo; Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel

Cohort C-GSK2302024A Group

EXPERIMENTAL

This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.

Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A; Drug: 5-Fluorouracil; Drug: Carboplatin AUC; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel; Drug: Trastuzumab

Cohort C-Placebo Group

PLACEBO COMPARATOR

This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.

Drug: Placebo; Drug: 5-Fluorouracil; Drug: Carboplatin AUC; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel; Drug: Trastuzumab

Cohort D-GSK2302024A-D14 Group

EXPERIMENTAL

This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.

Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A; Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel

Interventions

GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A BIOLOGICAL

6 or 8 injections at 3 weeks apart, injected intramuscularly in the deltoid or lateral region of the thigh.

Also known as: WT1 ASCI

Cohort A-GSK2302024A Group; Cohort B-GSK2302024A Group; Cohort C-GSK2302024A Group; Cohort D-GSK2302024A-D14 Group

Placebo DRUG

6 or 8 doses at 3 weeks apart of sucrose/mannitol-based formulation reconstituted with an oil-in-water emulsion, injected intramuscularly in the deltoid or lateral region of the thigh.

Cohort A-Placebo Group; Cohort B-Placebo Group; Cohort C-Placebo Group

Aromatase inhibitor DRUG

This treatment consisted of any aromatase inhibitor (e.g. letrozole or exemestane), administered intravenously in Cohort A Groups daily for either 18 (if 6 doses of WT1 ASCI/placebo) or 24 weeks (if 8 doses of WT1 ASCI/placebo).

Cohort A-GSK2302024A Group; Cohort A-Placebo Group

5-Fluorouracil DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses at 3 weeks apart, and for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Carboplatin AUC DRUG

Administered intravenously in Cohort C Groups in 6 doses at 3 weeks apart, on the same day as WT1 ASCI/placebo administration (Day 1 of each cycle).

Cohort C-GSK2302024A Group; Cohort C-Placebo Group

Cyclophosphamide DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses in Cohort C Groups and 6 doses 3 weeks apart in Cohorts A Placebo, B and D Groups, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Docetaxel DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 or 6 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Doxorubicin DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 6 doses 3 weeks apart (Cohort C patients with this schedule did not receive this treatment), while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Epirubicin DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Paclitaxel DRUG

Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: only in the 8 WT1 ASCI-dose schedule patients received 4 at 3 weeks apart or 12 weekly doses. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort A-Placebo Group; Cohort B-GSK2302024A Group; Cohort B-Placebo Group; Cohort C-GSK2302024A Group; Cohort C-Placebo Group; Cohort D-GSK2302024A-D14 Group

Trastuzumab DRUG

Administered intravenously in Cohort C Groups: for the 6 WT1 ASCI-dose schedule 3 or 6 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohort B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.

Cohort C-GSK2302024A Group; Cohort C-Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (36)

GSK Investigational Site

Newark, Delaware, 19713, United States

Location

GSK Investigational Site

Plantation, Florida, 33324, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109-5848, United States

Location

GSK Investigational Site

Bend, Oregon, 97701, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38120, United States

Location

GSK Investigational Site

Amarillo, Texas, 79106, United States

Location

GSK Investigational Site

Spokane, Washington, 99208, United States

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Namur, 5000, Belgium

Location

GSK Investigational Site

Lyon, 69373, France

Location

GSK Investigational Site

Saint-Herblain, 44805, France

Location

GSK Investigational Site

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

GSK Investigational Site

Erlangen, Bavaria, 91054, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45136, Germany

Location

GSK Investigational Site

Chemnitz, Saxony, 09116, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Aviano (PN), Friuli Venezia Giulia, 33081, Italy

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20141, Italy

Location

GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10126, Italy

Location

GSK Investigational Site

Trento, Trentino-Alto Adige, 38100, Italy

Location

GSK Investigational Site

Ryazan, 390011, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saint Petersburg, 197758, Russia

Location

GSK Investigational Site

Belfast, BT9 7AB, United Kingdom

Location

GSK Investigational Site

Bournemouth, BH7 7DW, United Kingdom

Location

GSK Investigational Site

Derby, DE22 3DT, United Kingdom

Location

GSK Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

GSK Investigational Site

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• Higgins M, Curigliano G, Dieras V, Kuemmel S, Kunz G, Fasching PA, Campone M, Bachelot T, Krivorotko P, Chan S, Ferro A, Schwartzberg L, Gillet M, De Sousa Alves PM, Wascotte V, Lehmann FF, Goss P. Safety and immunogenicity of neoadjuvant treatment using WT1-immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II/III breast cancer: a randomized Phase I study. Breast Cancer Res Treat. 2017 Apr;162(3):479-488. doi: 10.1007/s10549-017-4130-y. Epub 2017 Feb 7.

  PMID: 28176175 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aromatase Inhibitors; Fluorouracil; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: April 11, 2011
• Primary Completion: November 14, 2014
• Study Completion: November 14, 2014
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2017

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

FR (2); DE (8); US (8); GB (5); RU (3); BE (3); IT (7)