New immunotherapy options for advanced triple negative breast cancer
NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial
This study is testing a new combination of immunotherapy treatments for people with advanced triple-negative breast cancer to see if it can help them respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | atezolizumab, tiragolumab, chemotherapy, prednisone, ipilimumab |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06342037 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the safety and efficacy of tiragolumab in combination with atezolizumab and/or ipilimumab for patients with advanced triple-negative breast cancer (TNBC). The study aims to develop novel immunomodulatory strategies by utilizing advanced research tools to better understand the cancer-immune interactions specific to TNBC. It is a single center, non-blinded, multi-cohort, non-comparative trial focusing on patients with metastatic or incurable locally advanced TNBC who have specific biomarker profiles. The trial seeks to improve response rates and durability of treatment outcomes in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic or incurable locally advanced triple-negative breast cancer who have specific biomarker characteristics.
Not a fit: Patients with early-stage breast cancer or those who do not meet the specific eligibility criteria, such as having ER or HER2 positivity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide new effective treatment options for patients with advanced triple-negative breast cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination and methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metastatic or incurable locally advanced triple negative breast cancer with confirmation of Estrogen receptor (ER) and Human Epidermal growth factor Receptor 2 (HER2) negativity (ER \<10%, HER2 IHC 0, 1+ or 2+ with no amplification) on a histological biopsy of a metastatic lesion * Patients with PD-L1 negative disease determined using the Combined Positivity Score (CPS\<10) (Dako 22C3 IHC) OR previously treated with anti-PD(L)1 in the (neo)adjuvant or metastatic setting (irrespective of PD-L1 status). * Metastatic lesion accessible for histological biopsy * 18 years or older * World Health Organisation (WHO) performance status of 0 or 1 * Maximum of three lines of chemotherapy, including antibody-drug conjugates and Poly-ADP Ribose Polymerase (PARP)-inhibitors, for metastatic disease and with evidence of progression of disease * Measurable or evaluable disease according to RECIST1.1 * Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year. This does not apply to patients with de novo metastatic disease or patients who did not receive (neo)adjuvant chemotherapy. * Adequate bone marrow, kidney and liver function Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris * Symptomatic brain metastases (subjects with asymptomatic brain metastases are eligible if these are free of progression for at least 4 weeks) * History of leptomeningeal disease localization * History of having received other anticancer therapies within 2 weeks of start of the study drug * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivy to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation * History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (\>10 mg daily prednisone equivalents) or chronic infections. * Prior treatment with an anti-CTLA4 or anti-TIGIT antibody. * Administration of live vaccine within 30 days of planned start of study therapy. * Active other cancer * Positive test for hepatitis B, hepatitis C, HIV and/or Epstein Barr virus (EBV) * History of uncontrolled serious medical or psychiatric illness * Current pregnancy pregnancy or breastfeeding.
Where this trial is running
Amsterdam, North Holland
- Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marleen Kok, MD — Antoni van Leeuwenhoek
- Study coordinator: Marleen Kok, MD
- Email: m.kok@nki.nl
- Phone: +31205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.