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New treatment option for Metastatic Breast Cancer ( HER2 Negative)
Official title Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07193394
What this study is testing
What is Tucatinib (ONT-380)?
Tucatinib (ONT-380) is an investigational medicine, being studied as a potential treatment for metastatic breast cancer ( her2 negative).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Metastatic or unresectable breast cancer
- HER2-negative (defined as having an IHC 0+, IHC 1+, or IHC 2+ and ISH non-amplified, per ASCO/CAP guidelines) on last assessable tumor sample
- Having received ≥ 2 previous chemotherapy lines for advanced breast cancer: including at least one line of conjugated antibody, at the investigator's...
- Class IV or V somatic ERBB3 mutation as determined on a tumor sample obtained during the molecular screening step
You likely can't join if
- Having received any prior treatment targeting HER2. Prior treatment with trastuzumab deruxtecan is allowed, per label, in patients with HER2-low...
- History of allergic reactions to trastuzumab or tucatinib or chemically similar drugs
- Patients who are pregnant, breastfeeding, or planning a pregnancy from time of informed consent until 7 months after the final dose of study drug
- Inability to swallow pills or having a significant gastro-intestinal disease or a history of surgery which would preclude the adequate oral...
- Having used a strong CYP2C8 inhibitor within a duration of 5 half-lives prior to the first dose of study treatment, or have used a strong CYP3A4 or...
- Treatment with any systemic anti-cancer therapy (including hormonal therapy), non-central nervous system (CNS) radiation, or experimental agent ≤ 3...
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Metastatic or unresectable breast cancer
- HER2-negative (defined as having an IHC 0+, IHC 1+, or IHC 2+ and ISH non-amplified, per ASCO/CAP guidelines) on last assessable tumor sample
- Having received ≥ 2 previous chemotherapy lines for advanced breast cancer: including at least one line of conjugated antibody, at the investigator's discretion or if a germinal BRCA mutation is present, a PARP...
- Class IV or V somatic ERBB3 mutation as determined on a tumor sample obtained during the molecular screening step
- ECOG performance status ≤ 2 (Appendix A)
- Evaluable disease, per RECIST v1.1 Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study...
- Adequate organ function:
- Creatinine clearance ≥ 50 mL/min as calculated per institutional guidelines
- Total bilirubin ≤1.5 X upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if the conjugated bilirubin is ≤1.5 X ULN.
- Transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 2.5 X ULN (≤ 5 X ULN if the patient has liver metastases)
- Women of childbearing potential (WCBP) must have a negative serum pregnancy test \< 7 days prior to first dose of treatment. A woman is considered of childbearing potential following menarche and until becoming...
- WCBP (as defined above) and men with partners of childbearing potential must agree to use a highly effective birth control method during the study and for 3 months after completion of investigational treatment.
- Patients should be eligible for the treatment step according to the investigator's opinion.
- Patients must be covered by a health insurance plan.
- Patients able to provide signed informed consent.
What rules you out
- Having received any prior treatment targeting HER2. Prior treatment with trastuzumab deruxtecan is allowed, per label, in patients with HER2-low metastatic breast cancer (IHC 1+ or 2+, ISH non-amplified)
- History of allergic reactions to trastuzumab or tucatinib or chemically similar drugs
- Patients who are pregnant, breastfeeding, or planning a pregnancy from time of informed consent until 7 months after the final dose of study drug
- Inability to swallow pills or having a significant gastro-intestinal disease or a history of surgery which would preclude the adequate oral absorption of medications
- Having used a strong CYP2C8 inhibitor within a duration of 5 half-lives prior to the first dose of study treatment, or have used a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment...
- Treatment with any systemic anti-cancer therapy (including hormonal therapy), non-central nervous system (CNS) radiation, or experimental agent ≤ 3 weeks prior to the first dose of study treatment, except gonadotropin...
- Participation in another treatment clinical trial.
- Symptomatic and untreated brain metastases or brain metastases requiring urgent treatment, or brain metastases requiring a dose \> 2 mg of dexamethasone (or equivalent)
- Whole brain radiotherapy \< 21 days prior to first dose of treatment, stereotactic radiotherapy \< 7 days prior to first dose of treatment
- Leptomeningeal metastases
- Major surgery (including surgery of brain metastases) \< 21 days prior to first dose of treatment
- Evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment
- Have known myocardial infarction or unstable angina within 24 weeks prior to first dose of study treatment
- Have clinically significant cardiopulmonary disease such as:
- Ventricular arrhythmia requiring therapy,
- Uncontrolled hypertension (defined as persistent systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mm Hg on antihypertensive medications)
- Any history of symptomatic congestive heart failure
- Severe dyspnea at rest (CTCAE v5.0 Grade 3 or above) due to complications of advanced malignancy
- Hypoxia requiring supplementary oxygen therapy except when oxygen therapy is needed only for obstructive sleep apnea
- Presence of ≥ Grade 2 QTc prolongation on screening ECG
- Conditions potentially resulting in drug-induced prolongation of the QT interval or torsade de pointes:
- Congenital or acquired long QT syndrome
- Family history of sudden death
- History of previous drug-induced QT prolongation
- Current use of medications with known and accepted associated risk of QT prolongation (see row "Accepted Association" in Appendix D)
- Are known carriers of active Hepatitis B or Hepatitis C or have other known chronic liver disease
- Are known to be positive for human immunodeficiency virus (HIV)
- Altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
- Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
- Person deprived of liberty or under guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Limoges, France
- Marseille, France
- Nice, France
- Nîmes, France
- Rennes, France
- Saint-Cloud, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Limoges, France; Marseille, France; Nice, France; Nîmes, France; Rennes, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.