Metastatic Breast CancerPhase 2NCT04796324
Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.
A Phase 2 study testing Ixabepilone Injection in people with Metastatic Breast Cancer, run by Allarity Therapeutics at 19 sites in 7 countries.
Trial summary
The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes. 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?
- Ixabepilone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 1 Mar 2021to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent form
- Age 18 years or older
- Patients with histologically or cytological confirmed carcinoma of the breast. Patients with locally recurrent or metastatic disease
- Patients with HR-positive, HER negative tumors or triple negative tumors
- Previous chemotherapies (neo, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated.
- Maximum of three (3) prior chemotherapies in the metastatic setting in addition to any number of prior lines of endocrine therapy
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- Measurable disease
- Performance status of ECOG ≤ 1
- With an Ixabepilone DRP - score of >33% (Germany >67%)
- Adequate conditions as evidenced by the following clinical laboratory values:
- Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
- Hemoglobin > 6.2 mmol/L
- Platelets ≥ 100 x 109 /L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Serum bilirubin ≤ 1.0 ULN
- Alkaline phosphatase ≤ 2.5 x ULN or ≤5x ULN if documented liver/bone metastases. Creatinine ≤ 1.5 ULN
- Blood urea within normal limits
- Because of possible interference of cytochrome P450 3A4 activity by ixabepilone, patients were excluded from receiving the following medications at enrollment and while enrolled onto the study: amiodarone, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, and saquinavir
- Women of childbearing age and potential must be willing to use effective contraception during the study and at least until 90 days after last dose of study drug. Male patients or male patients who have female partners of childbearing age and potential must be willing to use effective contraception during the study and at least until 90 days after last dose of study drug. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections)
Who cannot join
- HER2 positive tumor
- Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- Patients with intracranial disease
- Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- Any active infection requiring parenteral or oral antibiotic treatment.
- Patients with grade 2, in case of diabetes grade 1 or greater neuropathy
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- Clinically significant (i.e. active) cardiovascular disease:
- Stroke within ≤ 6 months prior to day 1
- Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
- Myocardial infarction within ≤ 6 months prior to day 1
- Unstable angina
- New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
- Serious cardiac arrhythmia requiring medication
- Other medications or conditions, including surgery, that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
- Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy
- Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)
- Known prior severe hypersensitivity reactions to agents containing polyoxyethylated castor oil (Cremophor EL)
- Known hypersensitivity to fluoropyrimidines;
- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency;
- Patients must not continue treatment with the following strong inhibitors of CYP3A4:
- ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole. These therapies should be discontinued 72 hours prior to initiation of study drug therapy.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United Kingdom7 sites
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, EH4 2XR
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
St James Hospital
Leeds, LS9 7TF
Nottingham University Hospitals
Nottingham, Nottingham, NG5 1PB
Cancer Institute Singleton Hospital
Swansea, Wales, SA2 8QA
Somerset NHS Foundation Trust
Taunton, Somerset, TA1 5DA
Belgium4 sites
Onze-Lieve-Vrouwziekenhuis
Aalst, Aalst, 9300
Antwerp University Hospital
Antwerp, Edegem, 2650
Clin. Univ. Saint-Luc
Brussels, 1200
CHU de Liege, Oncology Department
Liège, 4000
Poland4 sites
Wojewodzki Szpital Specjalietyczny
Biała Podlaska, Biala Podlaska, 21-500
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Centrum Onkologii Ziemi Lubelskiej im.
Lublin, 20-090
Oddział Onkologii Klinicznej, Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu
Poznan, 61-848
About this study
Official title: Phase II, Open Label, Single Arm Study to Investigate Anti-tumor Effect of Ixabepilone in Patients With Locally Recurrent or Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP After Failure of an Anthracycline and Taxanes.
The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.
Read the detailed description
Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Drug Response Prediction) score of >67% (Belgium >33%) the patient can be included in the clinical study. Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ixabepilone Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixabepilone InjectionDrug
Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone | Experimental | Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Receives: Drug: Ixabepilone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
To evaluate the clinical benefit rate of ixabepilone using tumor measurements (e.g. CT or MRI etc.). One-sided comparisons of CBR between treatment and historic control will be performed, and will be repeated for subgroups defined by ER status.
Measured: Baseline to 24 weeks
Secondary outcomes (5)
Progression Free Survival (PFS)
PFS defined as time from inclusion until progressive disease(PD) according to RECIST v 1.0 or death of any reason
Measured: 1 year
Overall Survival (OS)
OS defined as time from inclusion until death
Measured: 1 year
Overall Response Rate (ORR) Defined as CR + PR
Objective response rate (ORR) as defined as complete response (CR) + partial response (PR) according to RECIST v 1.0
Measured: 1 year
Incidence of Treatment-Emergent Adverse Events Measured by NCI-CTCAE v.5.0
A description of the extent, duration and reversibility of ixabepilone elicited toxicity in target organs based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE v.5.0)
Measured: 1 year
Clinical Benefit Rate (CBR) - Fresh Biopsy Versus Archival
Assess difference in prediction based on archival and fresh biopsy from same patient (percent agreement in binary prediction, and difference in primary and secondary endpoints with archival versus fresh biopsies)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2024
- Study completion1 Nov 2025
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic 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
- Model description
- Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allarity Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796324
- Sponsor's protocol ID
- AL-2001
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2021
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Single Arm Study to Investigate Anti-tumor Effect of Ixabepilone in Patients With Locally Recurrent or Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP After Failure of an Anthracycline and Taxanes.
- ClinicalTrials.gov ID
- NCT04796324
- Acronym / sponsor ID
- AL-2001
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Allarity TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.
Detailed description
Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Drug Response Prediction) score of >67% (Belgium >33%) the patient can be included in the clinical study. Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone | Experimental | Drug: Ixabepilone InjectionIxabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent form
- Age 18 years or older
- Patients with histologically or cytological confirmed carcinoma of the breast. Patients with locally recurrent or metastatic disease
- Patients with HR-positive, HER negative tumors or triple negative tumors
- Previous chemotherapies (neo, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated.
Key exclusion criteria (21 listed)
- HER2 positive tumor
- Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- Patients with intracranial disease
- Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- Any active infection requiring parenteral or oral antibiotic treatment.
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 |
|---|---|---|
| Ixabepilone InjectionIxabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle | Drug | Ixabepilone |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: Baseline to 24 weeks
To evaluate the clinical benefit rate of ixabepilone using tumor measurements (e.g. CT or MRI etc.). One-sided comparisons of CBR between treatment and historic control will be performed, and will be repeated for subgroups defined by ER status.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Overall Response Rate (ORR) Defined as CR + PR
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events Measured by NCI-CTCAE v.5.0
Time frame: 1 year
Clinical Benefit Rate (CBR) - Fresh Biopsy Versus Archival
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone Injection in people with Metastatic Breast Cancer, run by Allarity Therapeutics at 19 sites in 7 countries.
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 19 inclusion and 21 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: stopped early, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Belgium, Poland, Finland, Germany and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Benefit Rate (CBR) (time frame: Baseline to 24 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 12 Mar 2026.