Predicting response in early HER2-positive breast cancer using on-treatment biopsies
Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer (BiOnHER)
This study is testing if taking biopsies from women with early HER2-positive breast cancer during their treatment can help predict how well they will respond to the therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Català d'Oncologia Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, trastuzumab, pertuzumab |
| Locations | 1 site (Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT05912062 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women with early HER2-positive invasive breast cancer who are eligible for neoadjuvant treatment. It aims to assess the impact of short-term neoadjuvant dual HER2-blockade on the transcriptomic profile of the cancer. Patients will undergo sequential tumor biopsies before and after one week of treatment to evaluate whether early on-treatment biomarkers can enhance the prediction of treatment response compared to pre-treatment samples. The study includes a discovery phase with RNA-Seq analysis and a validation phase to confirm the findings with a new cohort of patients.
Who should consider this trial
Good fit: Ideal candidates include adults with untreated invasive HER2-positive breast cancer who are eligible for neoadjuvant therapy.
Not a fit: Patients with non-invasive breast cancer or those who are not eligible for neoadjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate predictions of treatment response, allowing for personalized treatment plans for patients with HER2-positive breast cancer.
How similar studies have performed: While the approach of using on-treatment biopsies is gaining interest, this specific methodology is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent prior to beginning specific protocol procedures * Untreated invasive breast carcinoma eligible for neoadjuvant treatment * Histologically or cytologically confirmed human epidermal growth factor receptor 2 positive (HER2) Breast Cancer defined by ASCO/CAP guidelines based on the most recent analyzed biopsy or other pathology specimen; independently for estrogen receptor (ER) and progesterone receptor (PR) * Female and male patients * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function defined as: Absolute neutrophil count (ANC) ≥1.5 × 109/L, Hemoglobin (Hgb) ≥10 g/dL, Platelets \>100 000/mm3, Creatinine ≤1.6 mg/dL, ALT and AST ≤2.5 × ULN, Alkaline phosphatase ≤5 ULN, Total bilirubin ≤1.5 mg/dL * Baseline LVEF ≥50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan * Negative β-HCG pregnancy test (serum) for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after the menopause. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after last dose of investigational product * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Exclusion Criteria: * Known metastatic disease * Known or suspected hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances * Concurrent congestive heart failure or LVEF \<50% * History of significant comorbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent * Use of any investigational agent or participation in another therapeutic clinical trial concurrently or in the previous 30 days before the enrollment * Patients who are pregnant or breast-feeding * Women of child-bearing potential who are unable or unwilling to use contraceptive measures * Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator * Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies)
Where this trial is running
Hospitalet de Llobregat, Barcelona
- Institut Català d'Oncologia l'Hospitalet — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Sonia Pernas, MD PhD
- Email: contactfortrials_lh@iconcologia.net
- Phone: +34932607744
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.