NCT05698186Not yet recruitingPhase 3
Thero2-01S22 in HER2-positive Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 30 Nov 2022
- Start date
- May 2023
- Primary completion date
- May 2027
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05698186
- EU CT number
- 2024-516576-15-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 320
- From May 2023 to the primary completion date, May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not eligible for anti-HER2 therapy
- Patients previously treated at the metastatic setting by systemic treatment
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Not yet recruiting |
| Oncoradio Centre Oncogard Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Not yet recruiting |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.