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Breast CancerPhase 2NCT04781725

INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

A Phase 2 study testing INT230-6 and Saline injection in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
INT230-6 and Saline injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteCanada
Study dates
25 Mar 2021to 1 Mar 2023
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Female patients with newly diagnosed histologically confirmed primary invasive breast cancer currently not undergoing any treatment while awaiting surgery.
  • Patients with early, operable stage I to II breast cancer amendable for complete surgical resection as assessed by treating surgical oncologist.
  • Tumors must be clinically palpable by surgeon. Part I: ≥ 1.0 cm by palpation or on imaging. Part II: ≥ 1.5 cm by palpation or on imaging.
  • Histologic Bloom Richardson grade ≥2.
  • 4. Invasive ductal or lobular carcinoma, invasive carcinoma Not Otherwise Specified (NOS).
  • 5. ECOG PS 0-2 (Appendix A). 6. The participant (or legally acceptable representative if applicable) is able to provide written informed consent for the study.

Who cannot join

  • Locally advanced or metastatic breast cancer.
  • Prior therapy with chemotherapy or planned neoadjuvant chemotherapy.
  • Pre-dominant histology other than invasive ductal or lobular carcinoma or invasive carcinoma NOS.
  • Patients with an active infection.
  • Absolute Neutrophil Count < 1.5 x 10^9/L.
  • Patients with pre-existing renal impairment, Creatinine clearance calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of less than 50 mL/min/1.73m2.
Show all 13Show fewer
  • Any serious known immediate or delayed hypersensitivity reaction(s) to vinblastine or cisplatin or idiosyncrasy to drugs chemically related to the investigational drugs.
  • Known allergic reaction to local anesthetic (Xylocaine, Marcaine).
  • Concurrent medical condition requiring the use of immunosuppressive medications, or systemic corticosteroids at doses of greater than 10 mg Prednisone-equivalent Topical steroids and other localized corticosteroids are permitted. Use of steroids as prophylactic treatment for subjects with contrast allergies to diagnostic imaging contrast dyes will be permitted.
  • Concurrent use of a prohibited medication or planned use of any forbidden medications during treatment with INT230-6, or within 4 weeks prior to study drug administration, which include chemotherapy, immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer: systemic or intratumoral), other biologic therapy, investigational therapy, or hormonal therapy, cisplatin containing agents, and vinblastine containing agents while on treatment in this study. Other prohibited concomitant medications that will interact with vinblastine and cisplatin include mitomycin, phenytoin, CYP3A4 inhibitors (ketoconazole, voriconazole, clarithromycin, erythromycin), nephrotoxic drugs (aminoglycosides, amphotericin), or pure pyridoxine (pyridoxine contained in multivitamin is permitted). Use of other investigational drugs (drugs not marketed for any indication) within 4 weeks prior to study drug administration not permitted.
  • Pregnancy if patient is of childbearing age) or breast feeding.
  • Subjects with signs/symptoms suggestive of COVID-19 or known COVID-19 positive contacts in the past 14 days would be tested as per local Public Health and/or Institutional Guidelines. If patients are COVID-19 positive at the time of screening, they would be excluded from the trial.
  • Any underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events, or renders the patient ineligible to be on study.

Trial locations and contacts

1 site in 1 country.

Angel Arnaout, MD contact

6137985555

anarnaout@toh.on.ca

Canada1 site, 1 recruiting

  • The Ottawa Hospital Research Institute and Cancer Center

    Ottawa, Ontario, K1Y 4E9

    Angel Arnaout, MD, 613-798-5555 ext. 79622, aarnaout@toh.on.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

Read the detailed description

The study comprises 2 consecutive parts. The first part will be to test safety and feasibility of the dosing procedures. Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II.

Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on longest diameter. The control arm patients receive no treatment.

Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2 doses of INT230-6/saline injected weekly prior to breast surgery).

Conditions
Breast Cancer
Being tested
INT230-6, Saline injection
Keywords
window of opportunity, intratumoral, Ki67, complete pathologic response (PCR), immune activation, INT230-6, cisplatin, vinblastine, cell cycle arrest
Medical subject headings
Breast Neoplasms, Pathologic Complete Response

What participants receive

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

  • INT230-6Drug

    Also called Cisplatin, Vinblastine, 2-hydroxybenzoylaminooctanoate (SAHO)

    INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).

  • Saline injectionOther

    Standard 0.9 % NaCl Normal Saline

Study groups in NCT04781725
Study groupRoleWhat they receive
INT230-6 Treated ArmExperimentalPart I: Patients will receive up to 3 doses of INT230-6 injected weekly prior to breast surgery Part II: Patients will receive up to 2 intratumoral doses of INT230-6 (over a 15-day period) prior to breast surgery
Receives: Drug: INT230-6; Other: Saline injection
Control ArmPlacebo comparatorPart I: No intervention while awaiting surgery Part II: Placebo saline injection
Receives: Other: Saline injection

What is being measured

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

  1. The proportion of patients achieving a CCCA defined as a reduction in the proportion of cells staining positive for Ki67 as assessed by immunohistochemistry to less than a natural logarithm, or ≤2.7%, at the post-treatment specimen.

    Tumor's viable plus necrotic tissue, at the post-treatment specimen.

    Measured: presurgical window (period from diagnosis to surgery window of 3-6 weeks)

Secondary outcomes (4)

  1. The proportion of patients that achieved a complete pathologic response on surgical pathology as measured by the residual cancer burden index

    Assessed by the local pathologist at the time of definitive surgery in subjects with breast cancer

    Measured: presurgical window (period from diagnosis to surgery of 3-6 weeks)

  2. Immunohistochemical and gene expression markers of necrosis, apoptosis and tumor proliferation pathways.

    Comparison of pre (diagnostic biopsy) and post treatment (surgical resection) samples

    Measured: presurgical window (period from diagnosis to surgery of 3-6 weeks)

  3. Markers of immunomodulation including macrophages, NK, DC, CD4 T-cells, CD8 T-cells, regulatory T-cells.

    Comparison of pre (diagnostic biopsy) and post treatment (surgical resection) samples

    Measured: presurgical window (period from diagnosis to surgery of 3-6 weeks)

  4. Adverse effects of INT230-6 injected to breast cancers in healthy patients prior to surgery.

    overall safety of INT230-6 injected prior to surgery

    Measured: presurgical window (period from diagnosis to surgery of 3-6 weeks)

Timeline

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

  1. First posted4 Mar 2021
  2. Study start25 Mar 2021
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion1 Mar 2023 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781725
Sponsor's protocol ID
OTT 20-11 (IT-02)
Status last verified
Nov 2021
First submitted
25 Jan 2021
Last updated
17 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INT230-6 and Saline injection in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Angel Arnaout, MD (6137985555, anarnaout@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients achieving a CCCA defined as a reduction in the proportion of cells staining positive for Ki67 as assessed by immunohistochemistry to less than a natural logarithm, or ≤2.7%, at the post-treatment specimen. (time frame: presurgical window (period from diagnosis to surgery window of 3-6 weeks)). 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 NCT04781725.

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 17 Nov 2021.

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