BreastPhase 2TOPOLOGYNCT06162351
A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer
A Phase 2 study testing PLX038 in people with Breast and Cancer, run by Institut Curie at 2 sites in France.
Trial summary
Single arm phase II study for with primary objective to evaluate the efficacy of PLX038 on response rate for patients with pretreated, metastatic or locally advanced triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- PLX038
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Apr 2024to 15 May 2025
- 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
- Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures.
- Age ≥ 18 years.
- Females and males with cytologically or histologically confirmed breast carcinoma (either the primary or metastatic lesions).
- Locally advanced or metastatic disease that is not amenable to curative treatment.
- Triple negative breast cancer (both ER and PR <10%, HER2-negative or HER2-low).
- Measurable disease (per RECIST version 1.1).
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- Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with chemotherapy by an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient).
- Received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer.
- Patients with known gBRCA mutations must have received a PARP inhibitor in the metastatic setting.
- Patients whose cancer has a CPS score ≥10 must have received prior pembrolizumab unless (i) contra-indicated (ii) CPS score or pembrolizumab not available at time of first line treatment start.
- Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 5.0 Grade 1 or lower severity, except for stable sensory neuropathy (≤ Grade 2), alopecia (any grade), presence of clinically managed chronic autoimmune AEs from prior immune therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function (obtained within 14 days prior to treatment start) as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; ii. Hemoglobin (Hgb) ≥ 9 g/dL; iii. Platelet count ≥ 100 X 109/L; iv. Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert's disease (≤ 2 X ULN); v. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 X ULN (for patients with liver metastases ≤ 5 X ULN); vi. Alkaline phosphatase (AP) ≤ 3 X ULN (for patients with liver metastases, ≤ 5 X ULN); vii. Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula); viii. Women of childbearing potential (WCBP): negative serum pregnancy test.
- Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research.
Who cannot join
- Patients who had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start.
- Patients who had any major surgery within 28 days prior to inclusion.
- Patients with chronic inflammatory bowel disease and/or bowel obstruction.
- Concomitant use of other agents for the treatment of cancer or any investigational agent(s).
- Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded.
- Women who are either pregnant, lactating, planning to get pregnant.
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- Patients receiving pharmacotherapy for hepatitis B or C, tuberculosis, or HIV.
- Patients with known liver disease diagnosed with Child-Pugh A or higher cirrhosis.
- Prior stage III or IV malignancy (other than breast cancer).
- Severe/uncontrolled intercurrent illness within the previous 28 days prior to inclusion.
- Significant known cardiovascular impairment (NYHA CHF > grade 2, unstable angina, myocardial infarction within the previous 6 months prior to inclusion, or existing unstable cardiac arrhythmia).
- Any other significant medical, psychological, social or geographic conditions that in the opinion of the Investigator would impair study participation or cooperation.
- Patients deprived of their liberty or under guardianship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Curie
Paris, 75248 Cedex
Institut Curie
Saint-Cloud, 92210
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer
Single arm phase II study for with primary objective to evaluate the efficacy of PLX038 on response rate for patients with pretreated, metastatic or locally advanced triple negative breast cancer.
Read the detailed description
This is an open label, multi-centric phase II study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of PLX038 in locally-advanced or metastatic TNBC. Patient must have received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with chemotherapy by an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient) and received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer.
Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection).
All included patients will receive PLX038 as single agent as long as study is ongoing or until progression of disease, unacceptable toxicity, patient withdrawal of consent, Investigator decision, lost to follow-up, death, patient non-compliance, or study termination by Sponsor.
Tumor assessments must be performed according to the RECIST V1.1 criteria at inclusion and every 8 weeks (± 7 days) from inclusion until documented disease progression, withdrawal of consent, or death. Radiographic measurements must be performed to the RECIST specifications.
- Being tested
- PLX038
- Keywords
- Pretreated, Metastatic, Locally, Advanced triple negative
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX038Drug
Study treatment will be at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection).
Patients with a clinical benefit could be treated as long as study is ongoing. Patients are followed from inclusion until documented disease progression, withdrawal of consent, or death.
| Study group | Role | What they receive |
|---|---|---|
| Single arm: treatment with PLX038 | Experimental | Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection). Receives: Drug: PLX038 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best tumor response
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria).
Measured: 24 weeks
Secondary outcomes (11)
Time to response (TTR)
Time to response is defined as the time from inclusion to the first objective tumor response and will be estimated using Kaplan-Meier method
Measured: Until 24 months
SAEs (all grade, per NCI-CTCAE v5.0)
Serious adverse events (SAEs)according to NCI CTCAE v5.0, by grade and their relationship to PLX038
Measured: Until 30 days after the last dose of IMP (24 months + 30 days)
Correlation between PLX038 efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype)
Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (BRCAness)
Measured: Until 24 months
PK analysis
Maximum Plasma Concentration effect of PLX038
Measured: Until 24 months
Duration of Response (DoR)
DoR is defined as the time from the first documented PR or CR until the date of disease progression or the date of death. DoR will be computed using Kaplan-Meier
Measured: Until 24 months
Progression free survival (PFS)
PFS is defined as the time from inclusion to progression (per RECIST 1.1) or death, among included patients
Measured: Until 24 months
Overall Survival (OS)
PFS is defined as the time from inclusion to the first event among progression and death. OS is defined in the same way but only death is taken into account.
Measured: Until 24 months
AEs
Adverse events (AEs) according to NCI CTCAE v5.0, by grade and their relationship to PLX038
Measured: Until 30 days after the last dose of IMP (24 months + 30 days)
Correlation between PLX038 efficacy and homologous recombination (HR) defect, replication stress-related biomarkers such as SFLN11 expression
Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (SLFN11 expression)
Measured: Until 24 months
Correlation between PLX038 efficacy and homologous recombination (HR) defect replication stress-related biomarkers such as RB1 loss
Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (RB1 loss)
Measured: Until 24 months
PD analysis
Maximum Plasma Concentration of effect of PLX038
Measured: Until 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start17 Apr 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Why it stopped: No signal of significant toxicity and no signal of activity in the population of the TOPOLGY study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies 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
- Single arm phase II study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- ProLynx LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162351
- Sponsor's protocol ID
- IC 2020-16
- Acronym
- TOPOLOGY
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06162351
- Acronym / sponsor ID
- TOPOLOGY / IC 2020-16
- Keywords
- Pretreated, Metastatic, Locally, Advanced triple negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No signal of significant toxicity and no signal of activity in the population of the TOPOLGY study
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- ProLynx LLC
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 8 Dec 2023 (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.
Single arm phase II study for with primary objective to evaluate the efficacy of PLX038 on response rate for patients with pretreated, metastatic or locally advanced triple negative breast cancer.
Detailed description
This is an open label, multi-centric phase II study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of PLX038 in locally-advanced or metastatic TNBC. Patient must have received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with chemotherapy by an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient) and received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer.
Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection).
All included patients will receive PLX038 as single agent as long as study is ongoing or until progression of disease, unacceptable toxicity, patient withdrawal of consent, Investigator decision, lost to follow-up, death, patient non-compliance, or study termination by Sponsor.
Tumor assessments must be performed according to the RECIST V1.1 criteria at inclusion and every 8 weeks (± 7 days) from inclusion until documented disease progression, withdrawal of consent, or death. Radiographic measurements must be performed to the RECIST specifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm phase II study
| Arm | Type | Receives |
|---|---|---|
| Single arm: treatment with PLX038 | Experimental | Drug: PLX038Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures.
- Age ≥ 18 years.
- Females and males with cytologically or histologically confirmed breast carcinoma (either the primary or metastatic lesions).
- Locally advanced or metastatic disease that is not amenable to curative treatment.
- Triple negative breast cancer (both ER and PR <10%, HER2-negative or HER2-low).
Key exclusion criteria (13 listed)
- Patients who had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start.
- Patients who had any major surgery within 28 days prior to inclusion.
- Patients with chronic inflammatory bowel disease and/or bowel obstruction.
- Concomitant use of other agents for the treatment of cancer or any investigational agent(s).
- Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded.
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 |
|---|---|---|
| PLX038Study treatment will be at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection). Patients with a clinical benefit could be treated as long as study is ongoing. Patients are followed from inclusion until documented disease progression, withdrawal of consent, or death. | Drug | Single arm: treatment with PLX038 |
Primary outcome
Best tumor response
Time frame: 24 weeks
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria).
11 secondary outcomes
Time to response (TTR)
Time frame: Until 24 months
SAEs (all grade, per NCI-CTCAE v5.0)
Time frame: Until 30 days after the last dose of IMP (24 months + 30 days)
Correlation between PLX038 efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype)
Time frame: Until 24 months
PK analysis
Time frame: Until 24 months
Duration of Response (DoR)
Time frame: Until 24 months
Progression free survival (PFS)
Time frame: Until 24 months
Overall Survival (OS)
Time frame: Until 24 months
AEs
Time frame: Until 30 days after the last dose of IMP (24 months + 30 days)
Correlation between PLX038 efficacy and homologous recombination (HR) defect, replication stress-related biomarkers such as SFLN11 expression
Time frame: Until 24 months
Correlation between PLX038 efficacy and homologous recombination (HR) defect replication stress-related biomarkers such as RB1 loss
Time frame: Until 24 months
PD analysis
Time frame: Until 24 months
Results and safety
The study was stopped early (reason given: No signal of significant toxicity and no signal of activity in the population of the TOPOLGY study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLX038 in people with Breast and Cancer, run by Institut Curie at 2 sites in France.
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 15 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: stopped early, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 stopped early (reason given: No signal of significant toxicity and no signal of activity in the population of the TOPOLGY study). Results are not available in the source record.
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?
Best tumor response (time frame: 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 2 Jan 2026.