HER2-positive Breast CancerPhase 3NCT05698186
Thero2-01S22 in HER2-positive Breast Cancer
A Phase 3 study testing Thero2-01S22 in people with HER2-positive Breast Cancer, run by Institut de cancérologie Strasbourg Europe.
Trial summary
Trastuzumab and pertuzumab based regimen are the standard of care for patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC), significantly improving survival outcomes. However, an unmet medical need remain for patients with disease refractoriness and recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Thero2-01S22
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 15 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged > 18
- Metastatic setting of an histologically confirmed adenocarcinoma of the breast
- Performance status = 0, 1 or 2
- Metastatic disease requiring the initiation of an anti HER2 containing regimen
- First line treatment for metastatic disease
- Standard treatment including Trastuzumab and Pertuzumab in first line
Show all 10Show fewer
- Patients for whom a 3-month life expectancy is anticipated
- Baseline LVEF value > 50%, measured cardiac MRI or by echocardiography (Simpson's method) or MUGA scan within 12 weeks before initiation of the treatment. According to HERCEPTIN SPCs.
- Overexpression of HER2 in the invasive component of the primary tumor (3+ by ICH or 2+ with confirmation of positivity by FISH or CISH)
- Informed consent form signed
Who cannot join
- Patients not eligible for anti-HER2 therapy
- Patients previously treated at the metastatic setting by systemic treatment
- Serious cardiac illness or medical conditions disallowing administration of anti-HER2 therapy. According to HERCEPTIN and PERJETA SPCs.
- Known hypersensitivity to trastuzumab, pertuzumab, Thero2-01S22, murine proteins or to any of the excipients.
- Uncontrolled central nervous system metastatic lesion
- Patients who, for social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Efficacy and Safety Study of Thero2-01S22 add-on Therapy on Top of First-line Anti-HER2 Targeted Treatment of Patients With Metastatic Breast Cancer
Trastuzumab and pertuzumab based regimen are the standard of care for patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC), significantly improving survival outcomes. However, an unmet medical need remain for patients with disease refractoriness and recurrence. Interestingly, HER2 over-expression is associated with upregulation of vascular endothelial growth factor (VEGF) in cancer cells in vitro and in vivo. Preclinical studies indicated that VEGF expression is positively regulated by HER2 signaling. In the clinical setting, HER2 over-expression correlated significantly with VEGF over- expression in samples from patients with breast cancer. There is, therefore, a biologic rationale for targeting both HER2 and VEGF pathways in patients with HER2-positive breast cancer.
PURPOSE: The hypothesis that justifies this research is that the addition of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment will improve the efficacy of anti-HER2 targeted containing regimen at the metastatic setting for breast cancer.
Read the detailed description
This study is a two-part, multicenter, randomized, double-blind, placebo-controlled, Phase III trial.
Part 1 will confirm the recommended Phase III dose of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast, with the aim to obtain about 15 evaluable participants in Thero2-01S22 group and 15 in the placebo group.
Part 2 will assess the efficacy of Thero2-01S22 treatment at the recommended dose when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast. Approximately 290 participants will be randomized to receive Thero2-01S22 or Thero2-01S22 matching-placebo in combination with trastuzumab and pertuzumab.
Participants in both Part 1 and Part 2 will receive induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Thero2-01S22, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thero2-01S22Drug
Blinded recommended dose BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2
PlaceboDrug
Blinded placebo BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2
Thero2-01S22Drug
Blinded confirmed dose BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2
PlaceboDrug
Blinded placebo BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 | Experimental | Patients will receive Thero2-01S22 at the recommended dose and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab Receives: Drug: Thero2-01S22 |
| Part 1: Anti-HER2 targeted therapy containing regimen + Placebo | Placebo comparator | Patients will receive placebo and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab Receives: Drug: Placebo |
| Part 2: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 | Experimental | Patients will receive Thero2-01S22 at the confirmed dose and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab Receives: Drug: Thero2-01S22 |
| Part 2: Anti-HER2 targeted therapy containing regimen + Placebo | Placebo comparator | Patients will receive placebo and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: confirm the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast for Part 2
Incidence of adverse events considered possibly related to Thero2-01S22 that occur any time from the first dose intake of IMP or placebo to week 6.
Measured: Week 6
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Objective response rate (ORR) at week 6
Objective response rate (ORR): Percentage of patients whose disease decreased (Partial Response, PR) and / or disappears (Complete Response, CR) after treatment, according to RECIST V1.1 criteria, Eisenhauer et al. 2009.
Measured: Week 6
Secondary outcomes (12)
Part 1: determine the safety of the recommended dose of Thero2-01S22as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer
Safety: Incidence of adverse events per Common Terminology Criteria for Adverse Events (graded according to CTCAE) version 5.0 criteria from randomization to week 6
Measured: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of dose interruption
Number of dose interruptions of Thero2-01S22 trastuzumab, pertuzumab, and induction chemotherapy. Assessment period: from randomization to week 6
Measured: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of palatability
Palatability of oral Thero2-01S22 measured with visual analog scale. Assessment period: from randomization to week 6
Measured: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of treatment duration
Treatment duration (number of days) of therapy including Thero2-01S22 trastuzumab, pertuzumab, and induction chemotherapy. Assessment period: from randomization to week 6
Measured: From randomization to Week 6
Part 1: characterize exposure of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast
Determination of Area Under Curve (AUC) after oral Thero2-01S22 administration. PK samples to be collected at day 1 of cycle 1 and cycle 2 (each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Measured: PK samples at day 1 of cycle 1 and cycle 2(each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Part 1: characterize exposure of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast
Determination of Maximum Plasma Concentration (Cmax) after oral Thero2-01S22 administration. PK samples to be collected at day 1 of cycle 1 and cycle 2 (each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Measured: PK samples at day 1 of cycle 1 and cycle 2(each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Part 1: evaluate preliminary efficacy of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer
Objective response rate (ORR): Percentage of patients whose disease decreased (Partial Response, PR) and / or disappears (Complete Response, CR) after treatment, according to RECIST V1.1 criteria, Eisenhauer et al. 2009.
Calculated at week 6 after the last intake of IMP or placebo
Measured: Week 6
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Progression-Free Survival (PFS)
Progression-Free Survival (PFS): defined as the time interval from the date of randomization to the date of progression.
Events considered as progression include local or distant progression, appearance of a second cancer or death (all causes) whichever occurs first
Measured: Up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Overall Survival (OS)
Overall Survival (OS): defined as the time interval from the date of randomization to the date of death, regardless of disease progression
Measured: Up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of safety
Compare the effects of anti-HER2 targeted containing regimen with and without Safety: Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs) classified according to the CTCAE v5.0 criteria
Measured: Week 6 and up to the end of the study (24 months)
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of cardiotoxicity in terms of decrease of Left Ventricular Ejection Fraction (LVEF)
Decrease in Left Ventricular Ejection Fraction (LVEF) value compared to baseline according to the modality performed (ECG, MUGA, MRI)
Measured: From week 6 up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of cardiotoxicity in terms of cardiac toxicities revealed at physical examination
Cardiac toxicities revealed at physical examination, graded according to CTCAE v5.0 criteria
Measured: From week 6 up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 May 2023 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier PIVOT, MD, PhD, Study chair, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698186
- Sponsor's protocol ID
- 2022-009
- Status last verified
- Jan 2023
- First submitted
- 30 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Efficacy and Safety Study of Thero2-01S22 add-on Therapy on Top of First-line Anti-HER2 Targeted Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05698186
- Acronym / sponsor ID
- 2022-009
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 26 Jan 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.
Trastuzumab and pertuzumab based regimen are the standard of care for patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC), significantly improving survival outcomes. However, an unmet medical need remain for patients with disease refractoriness and recurrence. Interestingly, HER2 over-expression is associated with upregulation of vascular endothelial growth factor (VEGF) in cancer cells in vitro and in vivo. Preclinical studies indicated that VEGF expression is positively regulated by HER2 signaling. In the clinical setting, HER2 over-expression correlated significantly with VEGF over- expression in samples from patients with breast cancer. There is, therefore, a biologic rationale for targeting both HER2 and VEGF pathways in patients with HER2-positive breast cancer.
PURPOSE: The hypothesis that justifies this research is that the addition of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment will improve the efficacy of anti-HER2 targeted containing regimen at the metastatic setting for breast cancer.
Detailed description
This study is a two-part, multicenter, randomized, double-blind, placebo-controlled, Phase III trial.
Part 1 will confirm the recommended Phase III dose of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast, with the aim to obtain about 15 evaluable participants in Thero2-01S22 group and 15 in the placebo group.
Part 2 will assess the efficacy of Thero2-01S22 treatment at the recommended dose when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast. Approximately 290 participants will be randomized to receive Thero2-01S22 or Thero2-01S22 matching-placebo in combination with trastuzumab and pertuzumab.
Participants in both Part 1 and Part 2 will receive induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 | Experimental | Drug: Thero2-01S22Patients will receive Thero2-01S22 at the recommended dose and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab |
| Part 1: Anti-HER2 targeted therapy containing regimen + Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab |
| Part 2: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 | Experimental | Drug: Thero2-01S22Patients will receive Thero2-01S22 at the confirmed dose and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab |
| Part 2: Anti-HER2 targeted therapy containing regimen + Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo and induction therapy according to local practice with a taxane (docetaxel, paclitaxel, or nab-paclitaxel) or vinorelbine for 4 to 6 cycles in combination with pertuzumab and trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged > 18
- Metastatic setting of an histologically confirmed adenocarcinoma of the breast
- Performance status = 0, 1 or 2
- Metastatic disease requiring the initiation of an anti HER2 containing regimen
- First line treatment for metastatic disease
Key exclusion criteria (7 listed)
- Patients not eligible for anti-HER2 therapy
- Patients previously treated at the metastatic setting by systemic treatment
- Serious cardiac illness or medical conditions disallowing administration of anti-HER2 therapy. According to HERCEPTIN and PERJETA SPCs.
- Known hypersensitivity to trastuzumab, pertuzumab, Thero2-01S22, murine proteins or to any of the excipients.
- Uncontrolled central nervous system metastatic lesion
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 |
|---|---|---|
| Thero2-01S22Blinded recommended dose BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2 | Drug | Part 1: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 |
| PlaceboBlinded placebo BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2 | Drug | Part 1: Anti-HER2 targeted therapy containing regimen + Placebo |
| Thero2-01S22Blinded confirmed dose BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2 | Drug | Part 2: Anti-HER2 targeted therapy containing regimen + Thero2-01S22 |
| PlaceboBlinded placebo BID for three (3) consecutive days starting the day before anti-HER2 targeted therapy containing regimen, at cycle 1 and cycle 2 | Drug | Part 2: Anti-HER2 targeted therapy containing regimen + Placebo |
Primary outcome
Part 1: confirm the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast for Part 2
Time frame: Week 6
Incidence of adverse events considered possibly related to Thero2-01S22 that occur any time from the first dose intake of IMP or placebo to week 6.
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Objective response rate (ORR) at week 6
Time frame: Week 6
Objective response rate (ORR): Percentage of patients whose disease decreased (Partial Response, PR) and / or disappears (Complete Response, CR) after treatment, according to RECIST V1.1 criteria, Eisenhauer et al. 2009.
12 secondary outcomes
Part 1: determine the safety of the recommended dose of Thero2-01S22as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer
Time frame: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of dose interruption
Time frame: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of palatability
Time frame: Week 6
Part 1: determine the tolerability of the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer in terms of treatment duration
Time frame: From randomization to Week 6
Part 1: characterize exposure of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast
Time frame: PK samples at day 1 of cycle 1 and cycle 2(each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Part 1: characterize exposure of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast
Time frame: PK samples at day 1 of cycle 1 and cycle 2(each cycle is 21 days): before IMP or placebo intake, and at 5, 10, 15, 60, 120, 160 minutes after the intake
Part 1: evaluate preliminary efficacy of Thero2-01S22 when administered as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast cancer
Time frame: Week 6
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Progression-Free Survival (PFS)
Time frame: Up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of Overall Survival (OS)
Time frame: Up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of safety
Time frame: Week 6 and up to the end of the study (24 months)
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of cardiotoxicity in terms of decrease of Left Ventricular Ejection Fraction (LVEF)
Time frame: From week 6 up to 24 months
Part 2: compare the effects of anti-HER2 targeted containing regimen with and without Thero2-01S22 in terms of cardiotoxicity in terms of cardiac toxicities revealed at physical examination
Time frame: From week 6 up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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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.
Xavier PIVOT, MD, PhD study chair
Institut de cancérologie Strasbourg Europe
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thero2-01S22 in people with HER2-positive Breast Cancer, run by Institut de cancérologie Strasbourg Europe.
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 10 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: opening soon, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: confirm the recommended dose of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with metastatic breast for Part 2 (time frame: Week 6). The study lists 2 primary outcomes in all. 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 26 Jan 2023.