Clinical trial · Interventional
Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
A Safety and Bioactivity Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-Secreting Breast Tumor Vaccine for the Treatment of Patients With High Risk/ Metastatic HER-2/Neu- Overexpressing Breast Cancer With No Evidence of Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving trastuzumab together with cyclophosphamide and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic GM-CSF-secreting breast cancer vaccine | Biological | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
- description
- Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
- interventionNames
- Biological: allogeneic GM-CSF-secreting breast cancer vaccine
- Biological: trastuzumab
- Drug: cyclophosphamide
- Other: flow cytometry
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Procedure: biopsy
Primary outcomes (2)
- measure
- Safety as Assessed by Number of Participants Experiencing Toxicity
- timeFrame
- 4 years
- description
- Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast, meeting one of the following criteria:
* Metastatic disease
* High-risk disease, defined as early-stage disease with pathologic involvement of locoregional lymph nodes
* Patients who are/will be receiving standard adjuvant trastuzumab \[Herceptin®\] for high-risk disease will participate in this study during the single-agent trastuzumab portion of their therapy
* No clinical or radiographical evidence of active disease
* Not eligible for therapy of known curative potential for metastatic breast cancer
* HER2/neu-overexpressing disease, defined as HER2/neu positive by IHC 3+ staining or by FISH+ amplification
* Stable CNS disease allowed provided it has been adequately treated and is not under active treatment
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-1
* ANC \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum creatinine \< 2.0 mg/dL
* Serum bilirubin ≤ 2.0 mg/dL (unless elevation is due to known Gilbert's syndrome)
* AST/ALT ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Cardiac ejection fraction normal by MUGA OR ≥ 45% by ECHO
* No other malignancies within the past 5 years, except for carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer
* No prior or currently active autoimmune disease\* requiring management with systemic immunosuppression, including any of the following:
* Inflammatory bowel disease
* Systemic vasculitis
* Scleroderma
* Psoriasis
* Multiple sclerosis
* Hemolytic anemia or immune-mediated thrombocytopenia
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Sjögren syndrome
* Sarcoidosis
* Other rheumatologic disease
* No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
* HIV-negative
* No evidence of active acute or chronic infection
* No uncontrolled medical problems
* No active major medical or psychosocial problems that could be complicated by study participation
* No corn allergy
* No known severe hypersensitivity to trastuzumab (except for mild to moderate infusion reactions that are easily managed and do not recur) NOTE: \*Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed
PRIOR CONCURRENT THERAPY:
* Any number of prior chemotherapy regimens for metastatic breast cancer allowed
* Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed
* More than 28 days since prior and no concurrent systemic oral steroids
* Topical, ocular, or nasal steroids allowed
* More than 28 days since prior and no concurrent chemotherapy, radiotherapy, or biologic therapy (except trastuzumab)
* More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug
* Concurrent endocrine therapy or bisphosphonates allowedReferences
Publications (0)
Data not yet available