Phase 2 N=24 Treatment

SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer

Breastcancer · Breast Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT03066947 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jan 2021

Primary outcome: Primary: Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety] — 24; 11; 8; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SV-BR-1-GM (Biological); Cyclophosphamide (Drug); Interferon-alpha-2b (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: BriaCell Therapeutics Corporation
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]	24; 11; 8; 7; 6; 6	—
SECONDARY Duration of Treatment Emergent Adverse Events [Safety]	8	—
SECONDARY Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]	23	—
SECONDARY Objective Tumor Response Rate	—	—
SECONDARY Rate of Non-progression of Tumors	4	—
SECONDARY Durability of Tumor Response	105.5	—

Summary

This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation ~2 and ~4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.

Eligibility Criteria

Inclusion Criteria

1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.
Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
There is no need for steroids and patients have not had steroids at least 2 weeks
No individual tumor size is >50 mm3
ECOG status 30 and a creatinine >2.
Absolute granulocyte count 2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN.
Proteinuria >1+ on urinalysis or >1 gm/24hr.
Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.
New York Heart Association stage 3 or 4 cardiac disease.
A pleural effusion of moderate severity or worse.
Any woman of childbearing potential, unless she:
Agrees to take measures to avoid becoming pregnant during the study and
Has a negative serum pregnancy test within 7 days prior to starting treatment.
Women who are pregnant or nursing.
Patients with concurrent second malignancy. Persons with previous malignancies effectively treated and not requiring treatment for >24 months are eligible, provided there is unambiguous documentation that current local recurrence or metastatic site represents recurrence of the primary breast malignancy.
Patients who are HIV positive (by self-report) or have clinical or laboratory features indicative of AIDS.
14. Patients who require systemic steroids at a dose equivalent of >10 mg/day of prednisone. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Anticoagulants must be approved by the Investigator with notification of the Sponsor.
Patients who are on treatment for rheumatological or autoimmune disease unless approved by the Investigator in consultation with the Sponsor (e.g., as for replacement therapy for autoimmune thyroiditis or diabetes).
Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.
Male breast cancer patients.
Patients may not be on a concurrent clinical trial, unless approved by PI.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03066947). 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.