Metastatic Triple Negative Breast CancerPhase 2TACTICNCT04149444
A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer
A Phase 2 study testing Trifluridine/Tipiracil in people with Metastatic Triple Negative Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Triple Negative Breast Cancer
- What is being tested?
- Trifluridine/Tipiracil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2020to 9 Jun 2020
- 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
- Age ≥ 18 years
- Life expectancy of ≥ 3 months
- Histologically or cytologically confirmed locally recurrent or metastatic breast cancer that is Estrogen receptor negative, Progesterone receptor negative, and HER2 normal on local testing
- Up to three prior chemotherapy regimens for advanced and/or metastatic disease
- Prior therapy with an anthracycline and a taxane in the adjuvant or metastatic setting or documented unsuitability
- Patients who developed advanced or metastatic disease within 6 months of completing adjuvant therapy are eligible with no prior therapy for advanced disease.
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- Resolution of all chemotherapy- or radiation-related toxicities to ≤ grade 1 (except for stable sensory neuropathy ≤ grade 2 and alopecia) prior to commencement of study participation
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate renal function: creatinine clearance ≥ 40 mL/min Cockcroft and Gault formula
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count ≥ 100 x 10^9/L
- Adequate liver function: bilirubin ≤ 1.5 times the upper limits of normal (ULN), alanine aminotransferase (ALT ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN)
- Measurable disease (RECIST 1.1)
- Patients with known BRCA or ATM mutations or abnormalities (based on genomic profiling of tumor or germline genetic testing) are eligible if they meet all other inclusion criteria and have none of the exclusion criteria. The trial will not perform tumor genomic profiling or genetic testing but will document this information if available at study enrolment.
- Patients with known central nervous system (CNS) disease are eligible provided all of the following criteria are met:
- Measurable disease outside the CNS
- Metastases are limited solely to cerebellar and supratentorial lesions (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
- If corticosteroids are required, the patient must be on a stable dose or tapering dose of corticosteroids for 4 weeks prior to enrolment as therapy for CNS disease
- Anticonvulsants at a stable dose are allowed as long as the patient has been seizure free for 3 weeks prior to enrolment
- No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization
- No evidence of progression or haemorrhage after completion of CNS directed therapy
- Note: Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible, if all other criteria above are met.
- Women of child-bearing potential and males with female partners with child bearing potential must use highly effective contraceptive measures while taking Trifluridine/tipiracil and for 6 months after stopping treatment. Trifluridine/tipiracil may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier contraceptive method.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to take and retain oral medications
Who cannot join
- Radiation therapy encompassing more than 30% of marrow
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization.
- Leptomeningeal disease
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Trifluridine/tipiracil .
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because Trifluridine/tipiracil is an agent with the potential for teratogenic or abortifacient effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer
This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.
Read the detailed description
This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil (TAS-102) as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.
The trial will begin with a safety run-in of 10 patients treated as follows:
Cycle 1: Trifluridine/tipiracil administered at 30 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest. Intra-patient dose escalation to 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest for subsequent cycles in the absence of dose limiting toxicities. As long as at least 80% of patients tolerate dose escalation, the trial will proceed to the next stage.
Patients enrolled in stages I and II will start Trifluridine/tipiracil at 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest.
- Conditions
- Metastatic Triple Negative Breast Cancer
- Being tested
- Trifluridine/Tipiracil
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/TipiracilDrug
Also called TAS-102
Oral medication
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Dose escalation cohort - First 10 patients enrolled on study.
Trifluridine/Tipiracil 30mg/m2 - to start, if no significant dose limiting side effects the dose will be increased to 35mg/m2 for the duration of the trial.
After first 10 patients enrolled on study - Trifluridine/Tipiracil 35mg/m2
Each cycle is 28 days. Two doses per day during days 1-5 with a two day rest for days 6 and 7. Then two doses per day for days 8-12, followed by a rest period for days 13-28 with the next cycle starting the day after day 28. Receives: Drug: Trifluridine/Tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The Primary Endpoint ORR is calculated by taking the number of patients who at 8 weeks following initiation of Trifluridine/tipiracil have either a CR or a PR on first scan and dividing it over the total number of evaluable patients. Patients with stable disease are not included in this calculation.
Measured: 8 weeks
Secondary outcomes (5)
Progression Free Survival (PFS)
Progression free survival is defined as the time (in weeks) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. All patients will be followed until disease progression is documented according to RECIST 1.1 Criteria. The time measured in weeks between their baseline CT Scan and the first CT scan showing progressive disease as will be recorded as the progression free survival for that patient.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Disease Control Rate (DCR)
All patients who have either a Complete Response, Partial Response or exhibit stable disease for a minimum of 16 weeks will be counted as having achieved disease control. The number of patients attaining disease control will be divided by the total number of evaluable patients to attain a DCR for the entirety of the trial cohort.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Overall Survival
The death of any patient in the trial from any cause will be recorded and the amount of time from enrollment in the trial until death will be recorded in weeks. A median overall survival for the entire cohort will then be calculated using this information.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Safety and Tolerability: All adverse events experienced by all patients
All adverse events experienced by all patients exposed to Trifluridine/tipiracil will be recorded and graded according to CTCAE version 5. These will be compared to the side effect profile presented in both the product monograph as well as the previously published phase III trial upon which the Health Canada approval is based.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Quality of Life - Using EQ5D - A standardized questionnaire measuring quality of life
Quality of life will be scored using the EQ5D. Patients will fill out this questionnaire prior to each follow up visit and the results will be compared within the same patient from visit to visit.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 32 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startFeb 2020 (estimated)
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Why it stopped: Sponsor withdrew support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Patricia Tang, MD, Principal investigator, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149444
- Sponsor's protocol ID
- OZM-103
- Acronym
- TACTIC
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04149444
- Acronym / sponsor ID
- TACTIC / OZM-103
- Conditions
- Metastatic Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- Feb 2020 (estimated)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.
Detailed description
This is an open-label, single arm, multi-stage, phase II trial of Trifluridine/tipiracil (TAS-102) as a palliative treatment for patients with metastatic triple negative breast cancer who have failed both a taxane and anthracycline or have contraindications to these agents.
The trial will begin with a safety run-in of 10 patients treated as follows:
Cycle 1: Trifluridine/tipiracil administered at 30 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest. Intra-patient dose escalation to 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest for subsequent cycles in the absence of dose limiting toxicities. As long as at least 80% of patients tolerate dose escalation, the trial will proceed to the next stage.
Patients enrolled in stages I and II will start Trifluridine/tipiracil at 35 mg/m2 orally bid, 5 days per week, with 2 days of rest, for 2 weeks, followed by 14 day rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Drug: Trifluridine/TipiracilDose escalation cohort - First 10 patients enrolled on study. Trifluridine/Tipiracil 30mg/m2 - to start, if no significant dose limiting side effects the dose will be increased to 35mg/m2 for the duration of the trial. After first 10 patients enrolled on study - Trifluridine/Tipiracil 35mg/m2 Each cycle is 28 days. Two doses per day during days 1-5 with a two day rest for days 6 and 7. Then two doses per day for days 8-12, followed by a rest period for days 13-28 with the next cycle starting the day after day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years
- Life expectancy of ≥ 3 months
- Histologically or cytologically confirmed locally recurrent or metastatic breast cancer that is Estrogen receptor negative, Progesterone receptor negative, and HER2 normal on local testing
- Up to three prior chemotherapy regimens for advanced and/or metastatic disease
- Prior therapy with an anthracycline and a taxane in the adjuvant or metastatic setting or documented unsuitability
Key exclusion criteria (7 listed)
- Radiation therapy encompassing more than 30% of marrow
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization.
- Leptomeningeal disease
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Trifluridine/tipiracil .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine/TipiracilAlso: TAS-102Oral medication | Drug | ARM 1 |
Primary outcome
Overall Response Rate (ORR)
Time frame: 8 weeks
The Primary Endpoint ORR is calculated by taking the number of patients who at 8 weeks following initiation of Trifluridine/tipiracil have either a CR or a PR on first scan and dividing it over the total number of evaluable patients. Patients with stable disease are not included in this calculation.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Disease Control Rate (DCR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Overall Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Safety and Tolerability: All adverse events experienced by all patients
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 45 months.
Quality of Life - Using EQ5D - A standardized questionnaire measuring quality of life
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 32 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Tang, MD principal investigator
Tom Baker Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trifluridine/Tipiracil in people with Metastatic Triple Negative Breast Cancer, run by AHS Cancer Control Alberta 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 24 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Jun 2020. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Response Rate (ORR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.