A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
- Patients must have a histological/cytological diagnosis of metastatic breast cancer.
- Patients must have advanced and/or metastatic disease, for which no curative therapy
exists and for which systemic therapy is indicated.
- All patients must have an available formalin fixed paraffin embedded tissue block
(from their primary or metastatic tumour) within one year of enrollment and must have
provided informed consent for the release of the block, as well as for CTC and blood
samples for correlative studies and banking (See Section 17).
Patients should undergo re-biopsy prior to randomization if they have accessible tissue
which can be safely biopsied, or reasons for not doing so documented in the file.
- Presence of clinically and/or radiologically documented disease. All radiology
studies must be performed within 28 days prior to randomization (within 35 days if
All patients must have measurable disease as defined by RECIST 1.1.
The criteria for defining measurable disease are as follows:
Chest xray ≥ 20mm CT/MRI scan (with slice thickness <5mm) ≥10mm -> longest diameter
Physical exam (using calipers) ≥ 10mm Lymph nodes by CT scan ≥ 15mm -> measured in short
- ECOG performance of 0, 1 or 2.
- Age ≥ 18 years of age
- Previous Therapy
Previous major surgery is permitted provided that it has been at least 21days prior to
patient randomization and that wound healing has occurred.
Patients must have received at least one prior chemotherapy regimen for advanced or
metastatic disease unless:
1. they have relapsed within 6 months of completion of adjuvant chemotherapy
2. they have received taxane and anthracycline containing adjuvant chemotherapy.
Palliative therapy for breast cancer (chemotherapy, targeted, hormonal) is permitted
but no more than three prior chemotherapy regimens are permissible.
Patients may have received other therapies including immunotherapy, or with signal
Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed
between the last dose and enrollment to the trial. Exceptions may be made for low dose,
non-myelosuppressive radiotherapy after consultation with NCIC CTG.
- Laboratory Requirements (must be done within 7 days prior to randomization)
Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L
Serum creatinine ≤ 1.5 x ULN Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to
conditions such as Gilbert's disease) ALT and AST ≤ 3 x ULN (Note: ≤ 5 x ULN if documented
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements. Each patient must sign a consent form prior to
enrollment in the trial to document their willingness to participate.
Patients who cannot give informed consent (i.e. mentally incompetent patients, or those
physically incapacitated such as comatose patients) are not to be recruited into the
study. Patients competent but physically unable to sign the consent form may have the
document signed by their nearest relative or legal guardian. Each patient will be provided
with a full explanation of the study before consent is requested.
- Patients must be accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating centre. This implies there
must be reasonable geographical limits (for example: 2 hour's driving distance)
placed on patients being considered for this trial. Investigators must assure
themselves that the patients registered on this trial will be available for complete
documentation of the treatment, adverse events, response assessment and follow-up.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working
days of patient randomization.
- Patients with a history of other malignancies, except for adequately treated
non-melanoma skin cancer or solid tumours curatively treated with no evidence of
disease for > 3 years. (Please call NCIC CTG if any questions about the
interpretation of this criterion).
- Patients who are on immunosuppressive therapy or have known HIV infection or active
hepatitis B or C.
- Patients with active or uncontrolled infections or with serious illnesses or medical
conditions which would not permit the patient to be managed according to the
- Patients with significant cardiac (including uncontrolled hypertension) or pulmonary
disease, or active CNS disease or infection.
- Patients are not eligible if they have a known hypersensitivity to the study drug(s)
or their components.
- Patients with history of central nervous system metastases or untreated spinal cord
- Patients who have contraindications to treatment with paclitaxel and/or neuropathy >
- Women must be post-menopausal, surgically sterile or use two reliable forms of
contraception while on study and for 90 days after discontinuing therapy. Women of
childbearing potential must have a pregnancy test taken and proven negative within 7
days prior to randomization and must not be lactating. Men must be surgically sterile
or use a barrier method of contraception.
- Concurrent treatment with other investigational drugs or anti-cancer therapy.