Breast CancerNCT04882371
Comparison of MRI With PET / CT in the Evaluation of Response to Neoadjuvant Therapy Based on the Molecular Subtypes of Breast Cancer
An observational study of Breast Cancer and Chemotherapy Effect, run by Cem Ilgin Erol at 1 site in Turkey (Türkiye).
Trial summary
The current study aims to determine the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography- Computed Tomography (PET-CT) in predicting a pathological response of molecular subtypes of breast cancer to neoadjuvant chemotherapy (NAC). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect
- What is being tested?
- Chemotherapy, Magnetic Resonance Imaging (MRI) and Positron emission tomography - Copmputer Tomography (PET-CT)
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Aug 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with breast cancer who had undergone surgery after neoadjuvant chemotherapy
Who may be able to join
- Older than 18
- Breast cancer patients
- Had neoadjuvant chemotherapy before surgery
- Had undergone surgery after chemotherapy
Who cannot join
- Younger than 18
- History of surgery for breast cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe City Hospital
Istanbul, Kadikoy, 34100
About this study
The current study aims to determine the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography- Computed Tomography (PET-CT) in predicting a pathological response of molecular subtypes of breast cancer to neoadjuvant chemotherapy (NAC).
Read the detailed description
Eighty-eight patients with breast cancer who had undergone surgery after NAC were retrospectively analyzed between January 2018 and May 2020, at the general surgery clinic of Istanbul Medeniyet University Göztepe Training and Research Hospital. Demographic data, clinical findings, tumor markers, radiologic findings and pathology data were documented. With the use of MRI and / or PET-CT obtained before and after NAC, tumor staging was performed, and tumor size and the presence of metastatic lymph nodes and radiological response to NAC were evaluated. The response to NAC was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and contrast enhancement patterns described by Tozaki et al. on MRI, and the classification PET Response Criteria in Solid Tumors (PERCIST) on PET-CT. The postoperative pathology study reported the followings: the size and histopathologic type of the tumor, its hormone receptor status, staining intensities (Allred score), HER-2 positivity, Ki-67 proliferation percentages, and the molecular subtypes; the presence and number of metastatic lymph nodes, the response of the tumor and, the metastatic lymph node, if any, to NAC according to the Sataloff classification. Patients with a Sataloff score of "A" were considered to have a pCR, those with the scores of "B" or "C" were considered to have a partial response. When examining the Sataloff scores, the presence of pCR in both the primary tumor and axilla was evaluated and compared with the presence of radiological complete response on MRI and / or PET-CT. In addition, the sensitivities of MRI and PET-CT in predicting pCR in patients undergoing NAC were statistically compared based on the molecular subtypes. Patients whose MRI and PET-CT findings were consistent with histopathologic data were included in the "Radiology-Pathology agreement " group. The sensitivity of imaging methods was determined by examining the rates of agreement in the molecular subgroups. The Statistical Package for Social Sciences software for Windows version 20 (SPSS Inc.; Chicago, IL, USA) was used for all analyses. Normality was assessed by the Shapiro-Wilk test. Categorical variables were compared using chi-square or, where appropriate, Fisher's exact test. The Mc-Nemar test was used for paired categorical data. Trends in tables larger than 2x2 were examined with the linear-by-linear association test. Kruskal-Wallis test was used to compare non-normal distributed variables in three groups. Cohen's kappa (κ) was calculated to test the agreement between the classifications of radiology and pathology.
- Conditions
- Breast Cancer, Chemotherapy Effect
- Being tested
- Chemotherapy, Magnetic Resonance Imaging (MRI), Positron emission tomography - Copmputer Tomography (PET-CT)
- Keywords
- Breast Neoplasms, Neoadjuvant chemotherapy, RECIST, PERCIST
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Neoadjuvant Chemotherapy for Breast Cancer
Magnetic Resonance Imaging (MRI)Diagnostic test
Performed contrasted MRI for evaluate response of neoadjuvant chemotherapy
Positron emission tomography - Copmputer Tomography (PET-CT)Diagnostic test
Performed contrasted PET-CT for evaluate response of neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| MRI RECIST | Radiological responses were evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and changes in contrast enhancement patterns on MRI Receives: Drug: Chemotherapy; Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| PET-CT PERCIST | Radiological responses were evaluated according to the classification of PET Response Criteria in Solid Tumors (PERCIST) on PET-CT. Receives: Drug: Chemotherapy; Diagnostic Test: Positron emission tomography - Copmputer Tomography (PET-CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer
All patient had neoadjuvant chemotherapy, then a group of patient evaluated with MRI and the other group of patient with PET-CT
Measured: 2 months
Secondary outcomes (1)
Pathological evaluation of response to neoadjuvant chemotheraphy for breast cancer
Surgery was performed for all patient after neoadjuvant chemotherapy. Pathological datas were analyzed
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jan 2018
- Primary completion1 May 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cem Ilgin Erol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cem Ilgin Erol, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882371
- Sponsor's protocol ID
- 2020-0327
- Status last verified
- May 2021
- First submitted
- 8 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization, Fact Sheets, Detail, Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer
International Agency for Research on Cancer, Globocan 2018 Report. https://www.uicc.org/news/global-cancer-data-globocan-2018
Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, Moliterni A, Vazquez F, Byakhov MJ, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Magazzu D, Heinzmann D, Steinseifer J, Valagussa P, Baselga J. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014 May;15(6):640-7. doi: 10.1016/S1470-2045(14)70080-4. Epub 2014 Mar 20.
PubMed 24657003Cardoso F, Costa A, Norton L, Senkus E, Aapro M, Andre F, Barrios CH, Bergh J, Biganzoli L, Blackwell KL, Cardoso MJ, Cufer T, El Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano SH, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin UN, Mayer M, Merjaver SD, Nordstrom EB, Pagani O, Partridge A, Penault-Llorca F, Piccart MJ, Rugo H, Sledge G, Thomssen C, Van't Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E; European School of Oncology; European Society of Medical Oncology. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Breast. 2014 Oct;23(5):489-502. doi: 10.1016/j.breast.2014.08.009. Epub 2014 Sep 20. No abstract available.
PubMed 25244983Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.
PubMed 24529560Rastogi 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 18258986Abedi M, Farrokh D, Shandiz Homaei F, Joulaee A, Anbiaee R, Zandi B, Gity M, Sayah HR, Abedi MS. The validity of MRI in evaluation of tumor response to neoadjuvant chemotherapy in locally advanced breast cancer. Iran J Cancer Prev. 2013 Winter;6(1):28-35.
PubMed 25250107Gonzalez-Angulo AM, Morales-Vasquez F, Hortobagyi GN. Overview of resistance to systemic therapy in patients with breast cancer. Adv Exp Med Biol. 2007;608:1-22. doi: 10.1007/978-0-387-74039-3_1.
PubMed 17993229Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020.
PubMed 32606609Dhillon GS, Bell N, Ginat DT, Levit A, Destounis S, O'Connell A. Breast MR Imaging: What the Radiologist Needs to Know. J Clin Imaging Sci. 2011;1:48. doi: 10.4103/2156-7514.85655. Epub 2011 Oct 3.
PubMed 22059150Nunes LW, Schnall MD, Orel SG, Hochman MG, Langlotz CP, Reynolds CA, Torosian MH. Correlation of lesion appearance and histologic findings for the nodes of a breast MR imaging interpretation model. Radiographics. 1999 Jan-Feb;19(1):79-92. doi: 10.1148/radiographics.19.1.g99ja0379.
PubMed 9925393Rausch DR, Hendrick RE. How to optimize clinical breast MR imaging practices and techniques on Your 1.5-T system. Radiographics. 2006 Sep-Oct;26(5):1469-84. doi: 10.1148/rg.265055176.
PubMed 16973776Tozaki M, Kobayashi T, Uno S, Aiba K, Takeyama H, Shioya H, Tabei I, Toriumi Y, Suzuki M, Fukuda K. Breast-conserving surgery after chemotherapy: value of MDCT for determining tumor distribution and shrinkage pattern. AJR Am J Roentgenol. 2006 Feb;186(2):431-9. doi: 10.2214/ajr.04.1520.
PubMed 16423949Kim TH, Kang DK, Yim H, Jung YS, Kim KS, Kang SY. Magnetic resonance imaging patterns of tumor regression after neoadjuvant chemotherapy in breast cancer patients: correlation with pathological response grading system based on tumor cellularity. J Comput Assist Tomogr. 2012 Mar-Apr;36(2):200-6. doi: 10.1097/RCT.0b013e318246abf3.
PubMed 22446360Hegarty C, Collins CD. PET/CT and breast cancer. Cancer Imaging. 2010 Oct 4;10 Spec no A(1A):S59-62. doi: 10.1102/1470-7330.2010.9031.
PubMed 20880780
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MRI With PET / CT in the Evaluation of Response to Neoadjuvant Therapy Based on the Molecular Subtypes of Breast Cancer
- ClinicalTrials.gov ID
- NCT04882371
- Acronym / sponsor ID
- 2020-0327
- Conditions
- Breast Cancer, Chemotherapy Effect
- Keywords
- Breast Neoplasms, Neoadjuvant chemotherapy, RECIST, PERCIST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cem Ilgin ErolUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 11 May 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 current study aims to determine the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography- Computed Tomography (PET-CT) in predicting a pathological response of molecular subtypes of breast cancer to neoadjuvant chemotherapy (NAC).
Detailed description
Eighty-eight patients with breast cancer who had undergone surgery after NAC were retrospectively analyzed between January 2018 and May 2020, at the general surgery clinic of Istanbul Medeniyet University Göztepe Training and Research Hospital. Demographic data, clinical findings, tumor markers, radiologic findings and pathology data were documented. With the use of MRI and / or PET-CT obtained before and after NAC, tumor staging was performed, and tumor size and the presence of metastatic lymph nodes and radiological response to NAC were evaluated. The response to NAC was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and contrast enhancement patterns described by Tozaki et al. on MRI, and the classification PET Response Criteria in Solid Tumors (PERCIST) on PET-CT. The postoperative pathology study reported the followings: the size and histopathologic type of the tumor, its hormone receptor status, staining intensities (Allred score), HER-2 positivity, Ki-67 proliferation percentages, and the molecular subtypes; the presence and number of metastatic lymph nodes, the response of the tumor and, the metastatic lymph node, if any, to NAC according to the Sataloff classification. Patients with a Sataloff score of "A" were considered to have a pCR, those with the scores of "B" or "C" were considered to have a partial response. When examining the Sataloff scores, the presence of pCR in both the primary tumor and axilla was evaluated and compared with the presence of radiological complete response on MRI and / or PET-CT. In addition, the sensitivities of MRI and PET-CT in predicting pCR in patients undergoing NAC were statistically compared based on the molecular subtypes. Patients whose MRI and PET-CT findings were consistent with histopathologic data were included in the "Radiology-Pathology agreement " group. The sensitivity of imaging methods was determined by examining the rates of agreement in the molecular subgroups. The Statistical Package for Social Sciences software for Windows version 20 (SPSS Inc.; Chicago, IL, USA) was used for all analyses. Normality was assessed by the Shapiro-Wilk test. Categorical variables were compared using chi-square or, where appropriate, Fisher's exact test. The Mc-Nemar test was used for paired categorical data. Trends in tables larger than 2x2 were examined with the linear-by-linear association test. Kruskal-Wallis test was used to compare non-normal distributed variables in three groups. Cohen's kappa (κ) was calculated to test the agreement between the classifications of radiology and pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI RECIST | – | Drug: Chemotherapy, Diagnostic Test: Magnetic Resonance Imaging (MRI)Radiological responses were evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and changes in contrast enhancement patterns on MRI |
| PET-CT PERCIST | – | Drug: Chemotherapy, Diagnostic Test: Positron emission tomography - Copmputer Tomography (PET-CT)Radiological responses were evaluated according to the classification of PET Response Criteria in Solid Tumors (PERCIST) on PET-CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer who had undergone surgery after neoadjuvant chemotherapy
Key inclusion criteria (4 listed)
- Older than 18
- Breast cancer patients
- Had neoadjuvant chemotherapy before surgery
- Had undergone surgery after chemotherapy
Key exclusion criteria (2 listed)
- Younger than 18
- History of surgery for breast cancer
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 |
|---|---|---|
| ChemotherapyNeoadjuvant Chemotherapy for Breast Cancer | Drug | MRI RECIST, PET-CT PERCIST |
| Magnetic Resonance Imaging (MRI)Performed contrasted MRI for evaluate response of neoadjuvant chemotherapy | Diagnostic test | MRI RECIST |
| Positron emission tomography - Copmputer Tomography (PET-CT)Performed contrasted PET-CT for evaluate response of neoadjuvant chemotherapy | Diagnostic test | PET-CT PERCIST |
Primary outcome
Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer
Time frame: 2 months
All patient had neoadjuvant chemotherapy, then a group of patient evaluated with MRI and the other group of patient with PET-CT
1 secondary outcome
Pathological evaluation of response to neoadjuvant chemotheraphy for breast cancer
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- BackgroundWorld Health Organization, Fact Sheets, Detail, Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer
- BackgroundInternational Agency for Research on Cancer, Globocan 2018 Report. https://www.uicc.org/news/global-cancer-data-globocan-2018
- Background: PubMed 24657003Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, Moliterni A, Vazquez F, Byakhov MJ, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Magazzu D, Heinzmann D, Steinseifer J, Valagussa P, Baselga J. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014 May;15(6):640-7. doi: 10.1016/S1470-2045(14)70080-4. Epub 2014 Mar 20.
- Background: PubMed 25244983Cardoso F, Costa A, Norton L, Senkus E, Aapro M, Andre F, Barrios CH, Bergh J, Biganzoli L, Blackwell KL, Cardoso MJ, Cufer T, El Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano SH, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin UN, Mayer M, Merjaver SD, Nordstrom EB, Pagani O, Partridge A, Penault-Llorca F, Piccart MJ, Rugo H, Sledge G, Thomssen C, Van't Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E; European School of Oncology; European Society of Medical Oncology. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Breast. 2014 Oct;23(5):489-502. doi: 10.1016/j.breast.2014.08.009. Epub 2014 Sep 20. No abstract available.
- Background: PubMed 24529560Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.
- 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 25250107Abedi M, Farrokh D, Shandiz Homaei F, Joulaee A, Anbiaee R, Zandi B, Gity M, Sayah HR, Abedi MS. The validity of MRI in evaluation of tumor response to neoadjuvant chemotherapy in locally advanced breast cancer. Iran J Cancer Prev. 2013 Winter;6(1):28-35.
- Background: PubMed 17993229Gonzalez-Angulo AM, Morales-Vasquez F, Hortobagyi GN. Overview of resistance to systemic therapy in patients with breast cancer. Adv Exp Med Biol. 2007;608:1-22. doi: 10.1007/978-0-387-74039-3_1.
- Background: PubMed 32606609Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020.
- Background: PubMed 22059150Dhillon GS, Bell N, Ginat DT, Levit A, Destounis S, O'Connell A. Breast MR Imaging: What the Radiologist Needs to Know. J Clin Imaging Sci. 2011;1:48. doi: 10.4103/2156-7514.85655. Epub 2011 Oct 3.
- Background: PubMed 9925393Nunes LW, Schnall MD, Orel SG, Hochman MG, Langlotz CP, Reynolds CA, Torosian MH. Correlation of lesion appearance and histologic findings for the nodes of a breast MR imaging interpretation model. Radiographics. 1999 Jan-Feb;19(1):79-92. doi: 10.1148/radiographics.19.1.g99ja0379.
- Background: PubMed 16973776Rausch DR, Hendrick RE. How to optimize clinical breast MR imaging practices and techniques on Your 1.5-T system. Radiographics. 2006 Sep-Oct;26(5):1469-84. doi: 10.1148/rg.265055176.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy Effect, run by Cem Ilgin Erol at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer (time frame: 2 months). 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 NCT04882371, which also lists 29 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 11 May 2021.