Breast NeoplasmsNCT05068999
Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer
An observational study of Breast Neoplasms, run by Assiut University.
Trial summary
The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- shear wave elastography
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with breast cancer
Who may be able to join
- • Histologically confirmed infiltrating breast cancer
- Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
- Age ≥18
- Eastern Cooperative Oncology Group performance status ≤1
- Adequate bone marrow function (ANC >1.5 x 109/l, platelets >100 x 109/l)
- Adequate hepatic function (ALAT, ASAT and bilirubin <2.5 times upper limit of normal)
Show all 11Show fewer
- Adequate renal function (creatinine clearance >50 ml/min)
- LVEF ≥50% measured by echocardiography or MUGA
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Absence of any medical condition that would place the patient at unusual risk.
- Signed written informed consent
Who cannot join
- • previous radiation therapy or chemotherapy
- Other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
- Evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
- Evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
- Concurrent anti-cancer treatment or another investigational drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Assessment of Shear Wave Elastography Parameters to Assess the Response to Neoadjuvant Chemotherapy in Patients With Invasive Breast Cancer
The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer.
Read the detailed description
Neoadjuvant chemotherapy (NACT) is often used to treat patients with locally advanced breast cancer, large tumor but operable breast cancer, or proven lymph node metastasis. The advantage of NACT is that it can downstage tumor size and increase the rate of breast-conserving surgery as well as providing information on the drug response through assessment of the changes of tumor size . The pathological complete response has consistently been associated with good long-term outcomes, but is achieved in only 10%-20% of cases. Patients who achieve a pathological complete response have a better prognosis than those who do not . Higher rates of pathological complete response can be achieved when selecting for certain breast cancer subtypes and treatment regimens .
Breast cancer is a heterogeneous disease that can be divided into different subtypes by immunohistochemical marker expression or gene expression array data. A new surrogate intrinsic subtype was proposed at the St Gallen meeting to separate luminal A, luminal B (HER2-/HER2+), HER2-enriched, and triple-negative disease . Similarly, tumors may have different prognosis based on their molecular subtypes. The luminal A subtype has a better prognosis than the other subtypes, and the triple-negative subgroup has the worst prognosis . On the other hand, the triple-negative subtype is more sensitive to chemotherapy than luminal A and B breast cancer .
Current techniques available for monitoring response to NACT are positron emission tomography (PET) , sonography, mammography, magnetic resonance imaging (MRI) , and shear wave elastography (SWE) . Conventional sonography and mammography have poor reliability in evaluating the size of residual tumor after chemotherapy . SWE is a recently developed low-cost imaging technique for measuring tissue stiffness in a noninvasive and quantitative manner with high reproducibility . Tissue stiffness has been demonstrated to be significantly correlated with tumor growth as cancer development and progression require extensive reorganization of the extracellular matrix (ECM) . Increased deposition of collagen and other ECM molecules enhances the stiffness of tumoral stroma . Changes in tumor stiffness were significantly greater in patients who had a good response to NACT compared to those resistant to NACT. Breast cancer pre- and post-treatment stiffness obtained from SWE was significantly correlated with the presence of residual cancer . A study in showed that the SWE stiffness measured after 3 cycles of NACT and changes in stiffness from baseline were strongly associated with pCR after 6 cycles. The combination of the post-treatment SWE and grey scale ultrasound has also been shown to be promising for end-of-treatment identification of residual disease and thus response to NACT, with similar accuracies found in assessment by MRI .
Several histopathological classifications are available to categorize the tumor response to NACT. The Miller-Payne grading (MPG) and Residual Disease in Breast and Nodes (RDBN) are systems to assess the pathological response of NACT. MPG provides a five-step scale based on tumor cellularity in the excision/mastectomy specimen compared with the pretreatment core biopsy as follows: grade 1, no reduction in overall cellularity; grade 2, minor (<30%) loss of cellularity; grade 3, estimated 30%-90% reduction in tumor cells; grade 4, >90% loss of tumor cells; and grade 5, no invasive carcinoma (IC); ductal carcinoma in situ may be present.[30] RDBN uses the following formula: level 1, pathological complete response in breast and nodes, without or with carcinoma in situ, and levels 2-4, residual disease in three different amounts, calculated as 0.2 (residual breast tumor size in cm) + the index for the involved nodes (0 for no positive nodes, 1 for 1-4 nodes, 2 for 5-7 nodes, 3 for ≥8 nodes) + the Scarff-Bloom-Richardson grade (1, 2, or 3), which takes into account tumor size, lymph node stage, and histological grade to determine response.
- Conditions
- Breast Neoplasms
- Being tested
- shear wave elastography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear wave elastographyDevice
Shear wave elastography (SWE) is an emerging technology that provides information about the inherent elasticity of tissues by producing an acoustic radiofrequency force impulse, sometimes called an "acoustic wind," which generates transversely-oriented shear waves that propagate through the surrounding tissue and provide biomechanical information about tissue quality. Although SWE has the potential to revolutionize bone and joint imaging, its clinical application has been hindered by technical and artifactual challenges. Many of the stumbling blocks encountered during musculoskeletal SWE imaging are readily recognizable and can be overcome, but progressive advances in technology and a better understanding of image acquisition are required before SWE can reliably be used in musculoskeletal imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
shear wave elastography assessment in patients with invasive breast cancer.
measurement of shear wave elastography parameters in patients with invasive breast cancer before and after neoadjuvant chemotherapy and assess the residual cancer burden for each patient.
Measured: from october 2021 to october2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Awad Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068999
- Sponsor's protocol ID
- elastography in breast cancer
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mieog JS, van der Hage JA, van de Velde CJ. Neoadjuvant chemotherapy for operable breast cancer. Br J Surg. 2007 Oct;94(10):1189-200. doi: 10.1002/bjs.5894.
PubMed 17701939Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235.
PubMed 18258986von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
PubMed 22508812Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ; Panel members. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011 Aug;22(8):1736-47. doi: 10.1093/annonc/mdr304. Epub 2011 Jun 27.
PubMed 21709140Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
PubMed 10963602Hu Z, Fan C, Oh DS, Marron JS, He X, Qaqish BF, Livasy C, Carey LA, Reynolds E, Dressler L, Nobel A, Parker J, Ewend MG, Sawyer LR, Wu J, Liu Y, Nanda R, Tretiakova M, Ruiz Orrico A, Dreher D, Palazzo JP, Perreard L, Nelson E, Mone M, Hansen H, Mullins M, Quackenbush JF, Ellis MJ, Olopade OI, Bernard PS, Perou CM. The molecular portraits of breast tumors are conserved across microarray platforms. BMC Genomics. 2006 Apr 27;7:96. doi: 10.1186/1471-2164-7-96.
PubMed 16643655Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.
PubMed 17438091Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS. Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96. doi: 10.1002/cncr.22981.
PubMed 17722109Straver ME, Glas AM, Hannemann J, Wesseling J, van de Vijver MJ, Rutgers EJ, Vrancken Peeters MJ, van Tinteren H, Van't Veer LJ, Rodenhuis S. The 70-gene signature as a response predictor for neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2010 Feb;119(3):551-8. doi: 10.1007/s10549-009-0333-1. Epub 2009 Feb 13.
PubMed 19214742Kim C, Han SA, Won KY, Hong IK, Kim DY. Early Prediction of Tumor Response to Neoadjuvant Chemotherapy and Clinical Outcome in Breast Cancer Using a Novel FDG-PET Parameter for Cancer Stem Cell Metabolism. J Pers Med. 2020 Sep 17;10(3):132. doi: 10.3390/jpm10030132.
PubMed 32957507Tudorica A, Oh KY, Chui SY, Roy N, Troxell ML, Naik A, Kemmer KA, Chen Y, Holtorf ML, Afzal A, Springer CS Jr, Li X, Huang W. Early Prediction and Evaluation of Breast Cancer Response to Neoadjuvant Chemotherapy Using Quantitative DCE-MRI. Transl Oncol. 2016 Feb;9(1):8-17. doi: 10.1016/j.tranon.2015.11.016. Epub 2016 Jan 23.
PubMed 26947876Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
PubMed 24738612Li Q, Xiao Q, Li J, Wang Z, Wang H, Gu Y. Value of Machine Learning with Multiphases CE-MRI Radiomics for Early Prediction of Pathological Complete Response to Neoadjuvant Therapy in HER2-Positive Invasive Breast Cancer. Cancer Manag Res. 2021 Jun 28;13:5053-5062. doi: 10.2147/CMAR.S304547. eCollection 2021.
PubMed 34234550Evans A, Armstrong S, Whelehan P, Thomson K, Rauchhaus P, Purdie C, Jordan L, Jones L, Thompson A, Vinnicombe S. Can shear-wave elastography predict response to neoadjuvant chemotherapy in women with invasive breast cancer? Br J Cancer. 2013 Nov 26;109(11):2798-802. doi: 10.1038/bjc.2013.660. Epub 2013 Oct 29.
PubMed 24169359Lee SH, Chang JM, Han W, Moon HG, Koo HR, Gweon HM, Kim WH, Noh DY, Moon WK. Shear-Wave Elastography for the Detection of Residual Breast Cancer After Neoadjuvant Chemotherapy. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S376-84. doi: 10.1245/s10434-015-4828-1. Epub 2015 Aug 22.
PubMed 26297209
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Shear Wave Elastography Parameters to Assess the Response to Neoadjuvant Chemotherapy in Patients With Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT05068999
- Acronym / sponsor ID
- elastography in breast cancer
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer.
Detailed description
Neoadjuvant chemotherapy (NACT) is often used to treat patients with locally advanced breast cancer, large tumor but operable breast cancer, or proven lymph node metastasis. The advantage of NACT is that it can downstage tumor size and increase the rate of breast-conserving surgery as well as providing information on the drug response through assessment of the changes of tumor size . The pathological complete response has consistently been associated with good long-term outcomes, but is achieved in only 10%-20% of cases. Patients who achieve a pathological complete response have a better prognosis than those who do not . Higher rates of pathological complete response can be achieved when selecting for certain breast cancer subtypes and treatment regimens .
Breast cancer is a heterogeneous disease that can be divided into different subtypes by immunohistochemical marker expression or gene expression array data. A new surrogate intrinsic subtype was proposed at the St Gallen meeting to separate luminal A, luminal B (HER2-/HER2+), HER2-enriched, and triple-negative disease . Similarly, tumors may have different prognosis based on their molecular subtypes. The luminal A subtype has a better prognosis than the other subtypes, and the triple-negative subgroup has the worst prognosis . On the other hand, the triple-negative subtype is more sensitive to chemotherapy than luminal A and B breast cancer .
Current techniques available for monitoring response to NACT are positron emission tomography (PET) , sonography, mammography, magnetic resonance imaging (MRI) , and shear wave elastography (SWE) . Conventional sonography and mammography have poor reliability in evaluating the size of residual tumor after chemotherapy . SWE is a recently developed low-cost imaging technique for measuring tissue stiffness in a noninvasive and quantitative manner with high reproducibility . Tissue stiffness has been demonstrated to be significantly correlated with tumor growth as cancer development and progression require extensive reorganization of the extracellular matrix (ECM) . Increased deposition of collagen and other ECM molecules enhances the stiffness of tumoral stroma . Changes in tumor stiffness were significantly greater in patients who had a good response to NACT compared to those resistant to NACT. Breast cancer pre- and post-treatment stiffness obtained from SWE was significantly correlated with the presence of residual cancer . A study in showed that the SWE stiffness measured after 3 cycles of NACT and changes in stiffness from baseline were strongly associated with pCR after 6 cycles. The combination of the post-treatment SWE and grey scale ultrasound has also been shown to be promising for end-of-treatment identification of residual disease and thus response to NACT, with similar accuracies found in assessment by MRI .
Several histopathological classifications are available to categorize the tumor response to NACT. The Miller-Payne grading (MPG) and Residual Disease in Breast and Nodes (RDBN) are systems to assess the pathological response of NACT. MPG provides a five-step scale based on tumor cellularity in the excision/mastectomy specimen compared with the pretreatment core biopsy as follows: grade 1, no reduction in overall cellularity; grade 2, minor (<30%) loss of cellularity; grade 3, estimated 30%-90% reduction in tumor cells; grade 4, >90% loss of tumor cells; and grade 5, no invasive carcinoma (IC); ductal carcinoma in situ may be present.[30] RDBN uses the following formula: level 1, pathological complete response in breast and nodes, without or with carcinoma in situ, and levels 2-4, residual disease in three different amounts, calculated as 0.2 (residual breast tumor size in cm) + the index for the involved nodes (0 for no positive nodes, 1 for 1-4 nodes, 2 for 5-7 nodes, 3 for ≥8 nodes) + the Scarff-Bloom-Richardson grade (1, 2, or 3), which takes into account tumor size, lymph node stage, and histological grade to determine response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with breast cancer
Key inclusion criteria (11 listed)
- • Histologically confirmed infiltrating breast cancer
Key exclusion criteria (6 listed)
- • previous radiation therapy or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shear wave elastographyShear wave elastography (SWE) is an emerging technology that provides information about the inherent elasticity of tissues by producing an acoustic radiofrequency force impulse, sometimes called an "acoustic wind," which generates transversely-oriented shear waves that propagate through the surrounding tissue and provide biomechanical information about tissue quality. Although SWE has the potential to revolutionize bone and joint imaging, its clinical application has been hindered by technical and artifactual challenges. Many of the stumbling blocks encountered during musculoskeletal SWE imaging are readily recognizable and can be overcome, but progressive advances in technology and a better understanding of image acquisition are required before SWE can reliably be used in musculoskeletal imaging. | Device | – |
Primary outcome
shear wave elastography assessment in patients with invasive breast cancer.
Time frame: from october 2021 to october2022
measurement of shear wave elastography parameters in patients with invasive breast cancer before and after neoadjuvant chemotherapy and assess the residual cancer burden for each patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 17701939Mieog JS, van der Hage JA, van de Velde CJ. Neoadjuvant chemotherapy for operable breast cancer. Br J Surg. 2007 Oct;94(10):1189-200. doi: 10.1002/bjs.5894.
- Background: PubMed 18258986Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235.
- Background: PubMed 22508812von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.
- Background: PubMed 21709140Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ; Panel members. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011 Aug;22(8):1736-47. doi: 10.1093/annonc/mdr304. Epub 2011 Jun 27.
- Background: PubMed 10963602Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
- Background: PubMed 16643655Hu Z, Fan C, Oh DS, Marron JS, He X, Qaqish BF, Livasy C, Carey LA, Reynolds E, Dressler L, Nobel A, Parker J, Ewend MG, Sawyer LR, Wu J, Liu Y, Nanda R, Tretiakova M, Ruiz Orrico A, Dreher D, Palazzo JP, Perreard L, Nelson E, Mone M, Hansen H, Mullins M, Quackenbush JF, Ellis MJ, Olopade OI, Bernard PS, Perou CM. The molecular portraits of breast tumors are conserved across microarray platforms. BMC Genomics. 2006 Apr 27;7:96. doi: 10.1186/1471-2164-7-96.
- Background: PubMed 17438091Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.
- Background: PubMed 17722109Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS. Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96. doi: 10.1002/cncr.22981.
- Background: PubMed 19214742Straver ME, Glas AM, Hannemann J, Wesseling J, van de Vijver MJ, Rutgers EJ, Vrancken Peeters MJ, van Tinteren H, Van't Veer LJ, Rodenhuis S. The 70-gene signature as a response predictor for neoadjuvant chemotherapy in breast cancer. Breast Cancer Res Treat. 2010 Feb;119(3):551-8. doi: 10.1007/s10549-009-0333-1. Epub 2009 Feb 13.
- Background: PubMed 32957507Kim C, Han SA, Won KY, Hong IK, Kim DY. Early Prediction of Tumor Response to Neoadjuvant Chemotherapy and Clinical Outcome in Breast Cancer Using a Novel FDG-PET Parameter for Cancer Stem Cell Metabolism. J Pers Med. 2020 Sep 17;10(3):132. doi: 10.3390/jpm10030132.
- Background: PubMed 26947876Tudorica A, Oh KY, Chui SY, Roy N, Troxell ML, Naik A, Kemmer KA, Chen Y, Holtorf ML, Afzal A, Springer CS Jr, Li X, Huang W. Early Prediction and Evaluation of Breast Cancer Response to Neoadjuvant Chemotherapy Using Quantitative DCE-MRI. Transl Oncol. 2016 Feb;9(1):8-17. doi: 10.1016/j.tranon.2015.11.016. Epub 2016 Jan 23.
- Background: PubMed 24738612Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab awad mohamed ahmed (01011511722, rehabawad740@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shear wave elastography assessment in patients with invasive breast cancer. (time frame: from october 2021 to october2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068999, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.