Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00941408
Other study ID # BR03/17/08
Secondary ID
Status Recruiting
Phase N/A
First received July 16, 2009
Last updated January 13, 2014
Start date March 2009
Est. completion date December 2015

Study information

Verified date January 2014
Source National University Hospital, Singapore
Contact Soo Chin Lee, MBBS, MRCP
Phone 65 6672 4629
Email Soo_Chin_Lee@nuhs.edu.sg
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Observational

Clinical Trial Summary

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.


Description:

Abstract of Research Proposal:

Breast cancer is a heterogeneous disease, with various subtypes demonstrating differing biological behavior, prognosis, and response to therapeutic agents. Improving the understanding of the biology of breast cancer can result in better prognostication and therapy in individual patients, and has important clinical implications. While valuable scientific knowledge is generated from studies of breast cancer cell lines or animal models, such information generated in vitro may not fully reflect the in vivo model. Direct analysis of patient samples is important to validate in vitro findings, and represents a step closer to clinical application. Studying patient tumor samples for genetic and protein markers and correlating these analyses with clinical characteristics and outcomes could provide valuable insights into tumor biology in vivo, and leads to better understanding of tumor biology and resistance mechanisms. This is a single-centre study of biomarker analysis in breast tumors. A total of 400 patients with breast lesions for whom a diagnostic core biopsy is planned will be enrolled over 2 years. During the diagnostic tumor core biopsy, 3-4 additional tumor samples will be obtained through the same needle track for the purpose of this study. The tumor cores will be stored in liquid nitrogen for subsequent histopathological analysis; DNA, RNA and protein will be extracted from tumor cores for genetic, gene expression and proteomics studies. The patient's clinical progress will be tracked through the clinical case files. For patients in whom the clinical diagnostic biopsy yields a benign result, the samples obtained from them will serve as control specimens. For patients in whom the clinical diagnostic core biopsy confirms the diagnosis of breast cancer, the samples will be considered cases, and the following information will be tracked: histopathological characteristics of the tumor including ER/PR/c-erbB2 status and other known prognostic and predictive immunohistochemical markers (e.g., Ki67, p53, etc), anti-cancer treatment, progression-free and overall survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Procedure:
Diagnostic tumor core biopsy


Locations

Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Gaskell 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. — View Citation

Mouridsen 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. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Completed NCT01271738 - Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer N/A
Active, not recruiting NCT04132960 - Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis Phase 2
Completed NCT01980823 - Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer Early Phase 1
Completed NCT01218529 - Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors Phase 2
Completed NCT02891681 - Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment N/A
Terminated NCT01498588 - Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer Phase 2
Completed NCT00639171 - Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant
Recruiting NCT05582499 - Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy Phase 1/Phase 2
Completed NCT05584644 - A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
Completed NCT00243698 - A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions N/A
Completed NCT00807859 - Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer Phase 1
Completed NCT01118624 - Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer Phase 2
Completed NCT00626106 - QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT01042379 - I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Phase 2
Recruiting NCT05976620 - Clinical Study of 18F-FAPI-RGD in Breast Tumors
Terminated NCT02472353 - Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer Phase 2
Terminated NCT01194908 - Re-expression of ER in Triple Negative Breast Cancers Phase 1/Phase 2
Completed NCT02296801 - A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer Phase 2
Active, not recruiting NCT02187991 - Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer Phase 2