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A randomized, double-blinded, placebo-controlled, multicenter, phase II/III efficacy and safety study of oral TherO2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment of patients with Metastatic Breast Cancer TherO2-01S22 in HER2-positive breast cancer: TherO2-MBC Study
EU CTIS ID: 2024-516576-15-00
What this study is testing
(Phase III) To compare the effects of anti-HER2 targeted containing regimen with and without oral TherO2-01S22 in terms of Objective response rate (ORR).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women or men aged more than or equal to 18 years old
- Initial serum calcium and fasting blood glucose levels must be normal
- Metastatic setting of a histologically confirmed adenocarcinoma of the breast
- Overexpression of HER2 in the primary tumor or a metastatic lesion (3+ by ICH or 2+ with confirmation of positivity by FISH or SISH)
- Performance status = 0, 1 or 2
- Metastatic disease requiring the initiation of an anti HER2 containing regimen
You likely can't join if
- Patients not eligible for anti-HER2 therapy
- People with diabetes
- Persons deprived of liberty by judicial or administrative decision
- Persons not affiliated to a social security system or equivalent
- Persons receiving psychiatric medical care
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
See the full eligibility criteria
- Women or men aged more than or equal to 18 years old
- Initial serum calcium and fasting blood glucose levels must be normal
- Metastatic setting of a histologically confirmed adenocarcinoma of the breast
- Overexpression of HER2 in the primary tumor or a metastatic lesion (3+ by ICH or 2+ with confirmation of positivity by FISH or SISH)
- Performance status = 0, 1 or 2
- Metastatic disease requiring the initiation of an anti HER2 containing regimen
- First line treatment for metastatic disease
- Patients for whom a minimum of 3-month life expectancy is anticipated
- Baseline LVEF value > 50%, measured by cardiac MRI, by echocardiography (Simpson’s method) or by MUGA scan within 7 days before randomization. According to trastuzumab and pertuzumab Summary of Product Characteristics
- Informed consent form signed
- Patients not eligible for anti-HER2 therapy
- People with diabetes
- Persons deprived of liberty by judicial or administrative decision
- Persons not affiliated to a social security system or equivalent
- Persons receiving psychiatric medical care
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- Patients previously treated at the metastatic setting by systemic treatment
- Serious cardiac illness or medical conditions disallowing administration of anti-HER2 therapy. According to trastuzumab and pertuzumab SPCs
- Known hypersensitivity to trastuzumab, pertuzumab, TherO2-01S22, murine proteins or to any of the excipients
- Spinal cord compression and/or symptomatic or progressive brain metastases (Brain metastasis are not acceptable unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.