Clinical trial · Observational
Biomarker Study of Breast Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol aims to create a tissue bank of breast tumors obtained at the time of diagnosis for the identification of biomarkers for diagnosis, prognostication, and prediction of treatment response in breast cancer. While tissue banks now exist in major hospitals in Singapore to collect tumor specimens at the time of surgery, specimens collected at surgery from patients who had undergone pre-operative treatment represent a post-treatment sample and not a baseline, untreated sample. Such samples are intrinsically different from untreated samples, and have to be analyzed separately from untreated samples. However, they remain valuable samples, particularly if a pre-treatment sample has been obtained, providing paired pre- and post-treatment samples, which could provide valuable information on treatment-related tumor biomarker changes. A tissue bank comprising of samples collected during the diagnostic core biopsy thus represents a valuable supplement to existing tissue banks. Approximately 10-20% of patients diagnosed with non-metastatic breast cancer will require neoadjuvant chemotherapy. In addition, future clinical trials may include 'window-of-opportunity' studies during which biological therapy is administered for a short period (2-3 weeks) while an operable breast cancer patient is awaiting definitive surgery. The majority of early-stage breast cancer patients would be eligible for such trials, allowing the rapid recruitment of breast cancer patients. When coupled with analysis of surrogate markers of response (eg apoptosis, anti-angiogenic effects, etc), these unique clinical trials could provide valuable insights into the biological effects of new therapeutic agents in evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic tumor core biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnostic tumor core biopsy
- interventionNames
- Procedure: Diagnostic tumor core biopsy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years. * Suspicious breast lesion for which diagnostic core biopsy is planned. * Patients must not have received prior or scheduled to receive chemotherapy, hormonal therapy, radiotherapy, targeted therapy, or immunotherapy for the treatment of breast cancer. * Signed informed consent from patient or legal representative. Exclusion Criteria: * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
References
Publications (2)
- BACKGROUNDMouridsen HT, Andersen AP, Brincker H, Dombernowsky P, Rose C, Andersen KW. Adjuvant tamoxifen in postmenopausal high-risk breast cancer patients: present status of Danish Breast Cancer Cooperative Group trials. NCI Monogr. 1986;(1):115-8. PMID 3534583
- BACKGROUNDGaskell DJ, Hawkins RA, Sangsterl K, Chetty U, Forrest AP. Relation between immunocytochemical estimation of oestrogen receptor in elderly patients with primary breast cancer and response to tamoxifen. Lancet. 1989 May 13;1(8646):1044-6. doi: 10.1016/s0140-6736(89)92445-8. PMID 2566000