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Metastatic Breast CancerPhase 2NCT01656538

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

A Phase 2 study testing Paclitaxel and Reolysin in people with Metastatic Breast Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Paclitaxel and Reolysin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
7 sitesCanada
Study dates
20 Feb 2013to 14 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • Age ≥ 18 years of age
  • Previous Therapy
  • Surgery:
  • Previous major surgery is permitted provided that it has been at least 21days prior to patient randomization and that wound healing has occurred.
  • Chemotherapy:
  • Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease unless:
  • they have relapsed within 6 months of completion of adjuvant chemotherapy or
  • they have received taxane and/or anthracycline containing adjuvant chemotherapy.
  • Palliative therapy for breast cancer (chemotherapy, targeted, hormonal) is permitted but no more than three prior chemotherapy regimens are permissible.
  • Other Therapy:
  • Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors.
  • Patients must have recovered from all reversible toxicity related to prior chemotherapy and have adequate washout from prior chemotherapy, and investigational agents as follows:
  • longest of one of the following.
  • two weeks
  • standard cycle length of prior regimen (i.e 21 days for doxorubicin q3 weeks)
  • 5 half-lives for investigational drugs.
  • Radiation:
  • 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)
  • Hematology:
  • Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L
  • Biochemistry:
  • 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 liver metastasis)
  • Proteinuria <2g/24hrs (screen using spot testing; if ≥ grade 2 repeat with mid-stream urine; if still ≥ grade 2, then urine collection for 24 hours to confirm <2g/24hrs).
  • 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.

Who cannot join

  • 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.
  • 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 compression.
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  • Patients who have contraindications to treatment with paclitaxel and/or neuropathy > grade 1.
  • Women must be post-menopausal, surgically sterile or use two reliable forms of contraception while on study and for 6 months 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Paclitaxel, Reolysin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01656538
Study groupRoleWhat they receive
Paclitaxel plus ReolysinExperimentalPaclitaxel given weekly on days 1, 8, 15 every 4 weeks plus reolysin days 1, 2, 8, 9, 15 and 16.
Receives: Drug: Paclitaxel; Drug: Reolysin
PaclitaxelActive comparatorPaclitaxel given weekly on days 1, 8 and 15 every 4 weeks.
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: 24 months

Secondary outcomes (3)

  1. Response rate

    To investigate additional potential measures of efficacy including Objective response rate, overall survival (OS) and CTC counts.

    Measured: 24 months

  2. Tumour and tissue response of potential molecular factors

    Potential molecular factors which may be prognostic or predictive of response by assessment of archival tumour tissue, CTCs, and serial blood samples

    Measured: 24 months

  3. Number of patients with adverse events

    To determine the tolerability and toxicity of reolysin and paclitaxel when given in combination.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2012 (estimated)
  2. Study start20 Feb 2013
  3. Primary completion18 Nov 2016
  4. Study completion14 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01656538
Sponsor's protocol ID
I213
Status last verified
Apr 2020
First submitted
31 Jul 2012
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bernstein V, Ellard SL, Dent SF, Tu D, Mates M, Dhesy-Thind SK, Panasci L, Gelmon KA, Salim M, Song X, Clemons M, Ksienski D, Verma S, Simmons C, Lui H, Chi K, Feilotter H, Hagerman LJ, Seymour L. A randomized phase II study of weekly paclitaxel with or without pelareorep in patients with metastatic breast cancer: final analysis of Canadian Cancer Trials Group IND.213. Breast Cancer Res Treat. 2018 Jan;167(2):485-493. doi: 10.1007/s10549-017-4538-4. Epub 2017 Oct 13.

    PubMed 29027598

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Reolysin in people with Metastatic Breast Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01656538, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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