Phase 2 Completed N=60 Randomized Treatment

Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer

Breast Cancer

Source: ClinicalTrials.gov NCT00971737 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcomePrimary: Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events — 0; 2 adverse events

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events	0; 2	—
PRIMARY Clinical Benefit (CB) as Assessed by Progression Free Survival at Six Months	33; 37	—
PRIMARY HER-2/Neu-specific Immune Responses as Measured by Number of Participants With Positive for Delayed-type Hypersensitivity (DTH) Response	14; 16	—
PRIMARY Pharmacodynamics of Peripheral CD4+CD25+ Regulatory T Cells	—	—
SECONDARY Immune Priming in In-vivo Vaccine-site Biopsies	—	—
SECONDARY Enumeration of CD8+ T Cells Specific for hTERT by ELISPOT	—	—
SECONDARY Characterization of the T-cell Memory Pool Pre- and Post-vaccination	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00971737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.