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COMPLETEDPHASE2

A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer

A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

NCT01656538•Canadian Cancer Trials Group

View on ClinicalTrials.gov

Summary

Researchers doing this study want to evaluate the side effects of Reolysin when given together with paclitaxel. As these drugs have not been given together before, 6-9 patients will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.

Detailed Description

The purpose of the randomized part of this study is to find out if giving Reolysin in combination with paclitaxel can offer better results than standard therapy with paclitaxel.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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) 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.
•For patients who have not had a tissue biopsy within the last 12 months, a repeat biopsy is strongly recommended but is not mandated providing that archival tissue is available.
•Re-biopsy is recommended if \> 1 year since last biopsy.
•Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).
•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 axis
•ECOG performance of 0, 1 or 2.
+34 more criteria

Exclusion Criteria

•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 protocol.
•Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection.

Locations (7)

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Key Dates

Start Date

February 20, 2013

Primary Completion Date

November 18, 2016

Completion Date

February 14, 2018

Last Updated

August 4, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Paclitaxel

DRUG

Reolysin

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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