Clinical trial · Interventional
Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer
A Randomized, Open-Label Comparative Study of Combination Therapy With Cyclophosphamide and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine With or Without Trastuzumab for the Treatment of Metastatic Breast Cancer That Does NOT Over-express HER-2/Neu
- 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: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and trastuzumab, may increase the number of immune cells and make the immune response stronger. It is not yet known whether giving cyclophosphamide together with vaccine therapy is more effective with or without trastuzumab in treating patients with metastatic breast cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving cyclophosphamide together with vaccine therapy and to see how well it works compared with giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic GM-CSF-secreting breast cancer vaccine | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cyclophosphamide and Vaccine only
- description
- Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
- interventionNames
- Biological: allogeneic GM-CSF-secreting breast cancer vaccine
- Drug: cyclophosphamide
- type
- EXPERIMENTAL
- label
- Cyclophosphamide, Vaccine and Trastuzumab
- description
- Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
- interventionNames
- Biological: allogeneic GM-CSF-secreting breast cancer vaccine
- Biological: trastuzumab
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 * Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC * Stage IV disease * Must not be eligible for therapy of known curative potential for metastatic breast cancer * Measurable or evaluable disease * Stable CNS disease allowed provided that it's adequately treated and 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 * Platelets \> 100,000/mm\^3 * Serum bilirubin \< 2.0 mg/dL (unless due to Gilbert syndrome) * AST and ALT \< 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 5 times ULN * Serum creatinine \< 2.0 mg/dL * Ejection fraction normal by MUGA OR ≥ 50% by echocardiogram * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed * No prior or concurrent 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 * Sjogren syndrome * Sarcoidosis * Other rheumatologic disease * No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated * No active major medical or psychosocial problems that could be complicated by study participation * No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest * No uncontrolled medical problems * No evidence of active acute or chronic infection * No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur * No allergy to corn PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab) * Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed * More than 28 days since prior and no other concurrent participation in an investigational new drug trial * More than 28 days since prior and no other concurrent systemic oral steroids * Topical, ocular, and nasal steroids allowed * No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine
References
Publications (0)
Data not yet available