Breast Cancer Clinical Trial
— BSGILABOfficial title:
A Prospective Study to Evaluate Dynamic Breast-Specific Gamma Imaging in Monitoring Tumor Responses in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
NCT number | NCT02556684 |
Other study ID # | BSGILAB001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | October 2020 |
A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited over a 2-year period. This study will give clinicians further insight into the usefulness of ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria - 18 Years and older, and histologic proof of breast cancer (invasive ductal or lobular carcinoma-not breast sarcoma or lymphoma) - Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer. - Patients must be able to undergo neoadjuvant chemotherapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy Exclusion Criteria - Previously treated cancer other than non melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater. - Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan). - Previous chemotherapy or hormonal therapy for breast cancer. - Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy - Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery. - Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment. - Pregnant or lactating females. - Inadequate hematologic, renal and liver function as measured by CBC (WBC<4.0 x 109, Hb<100 g/L, plt count<100 x 109), and abnormal hepatic transaminases (AST, ALT, GGT, alkaline phosphatase>2x normal), elevated total bilirubin, and elevated serum creatinine (Cr>110 micromol/L). - Any contraindication to undergoing MRI or BSGI. |
Country | Name | City | State |
---|---|---|---|
China | Cancer institute | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Gong Z, Williams MB. Comparison of breast specific gamma imaging and molecular breast tomosynthesis in breast cancer detection: Evaluation in phantoms. Med Phys. 2015 Jul;42(7):4250-9. doi: 10.1118/1.4922398. — View Citation
Kelley KA, Crawford JD, Thomas K, Gardiner SK, Johnson NG. A Comparison of Breast-Specific Gamma Imaging of Invasive Lobular Carcinomas and Ductal Carcinomas. JAMA Surg. 2015 Aug;150(8):816-8. doi: 10.1001/jamasurg.2015.0965. — View Citation
Lee HS, Ko BS, Ahn SH, Son BH, Lee JW, Kim HJ, Yu JH, Kim SB, Jung KH, Ahn JH, Cha JH, Kim HH, Lee HJ, Song IH, Gong G, Park SH, Lee JJ, Moon DH. Diagnostic performance of breast-specific gamma imaging in the assessment of residual tumor after neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2014 May;145(1):91-100. doi: 10.1007/s10549-014-2920-z. Epub 2014 Mar 27. — View Citation
Sun Y, Wei W, Yang HW, Liu JL. Clinical usefulness of breast-specific gamma imaging as an adjunct modality to mammography for diagnosis of breast cancer: a systemic review and meta-analysis. Eur J Nucl Med Mol Imaging. 2013 Feb;40(3):450-63. doi: 10.1007/s00259-012-2279-5. Epub 2012 Nov 14. Review. — View Citation
Yoon HJ, Kim Y, Chang KT, Kim BS. Prognostic value of semi-quantitative tumor uptake on Tc-99m sestamibi breast-specific gamma imaging in invasive ductal breast cancer. Ann Nucl Med. 2015 Aug;29(7):553-60. doi: 10.1007/s12149-015-0977-3. Epub 2015 May 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity/Specificity | BSGI have a high sensitivity/specificity t in predicting which LABC patients achieve a complete pathologic response (pCR) following neo-adjuvant chemotherapy | 2 YEARS | |
Secondary | pathologic complete response | BSCGI might changes in clinical management by identifying non-responders earlier than with other examinations. | 2 YEARS | |
Secondary | Overall Survival | BSGI predict long-term survival | 2 YEARS |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |