Breast CancerNCT05951699
Mini-invasive Detection of Residual Disease in Breast Cancer Patients in Remission After Primary Chemotherapy
An observational study of Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- minimally invasive preoperative image-guided vacuum-assisted biopsy
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2022to 31 Dec 2025
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: cT1-cT2-cT3 cN0-cN1 breast cancer patients, either with clinical/radiological complete response, or with <1 cm residual breast disease after systemic primary treatment
Who may be able to join
- Radiologically confirmed unifocal cT1-cT2-cT3 cN0-cN1 breast cancer patients indicated for primary chemotherapy
- Histologically confirmed HER2-positive, triple negative or luminal B HER2-positive invasive breast cancer
- Clinical/radiological complete response or residual breast disease <1 cm after primary chemotherapy
- Absence of locoregional relapse or distant metastasis
- Signed informed consent to participate.
Who cannot join
- Disease surgically inoperable or surgery not performed
- Multifocal disease or presence of microcalcifications at imaging.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Gabriele Martelli, MD, +39 02 2390 3436, gabriele.martelli@istitutotumori.mi.it
Chiara Listorti, MD, +39 02 2390 2169, chiara.listorti@istitutotumori.mi.it
About this study
Official title: Prospective Clinical Trial to Assess a Mini-invasive Pre-surgical Procedure to Detect Residual Breast or Axillary Disease in Patients With cT1-T2-T3 cN0/N1 Breast Cancer in Complete Clinical/Radiological Remission After Primary Chemotherapy
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease.
The aims of this study are:
Read more
- To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
- To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip.
The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.
Read the detailed description
Systemic neoadjuvant treatment was introduced in the 1990s (1,2) mainly for advanced (cT2, cT3) breast cancer to reduce the extent of disease and hence allow conservative surgery instead of mastectomy.
Studies (3-6) demonstrated that pathologic complete response (pCR) in the breast and/or axilla after neoadjuvant treatment predicted better overall survival (OS), better distant relapse-free survival (DRS), and lower mortality.
More recently, targeted neoadjuvant therapies achieve pCR in over 60% of patients (7,8) and in up to 70% of patients with HER2-positive or triple negative subtypes that are generally associated with poorer outcomes (9).
Ultrasound, mammography and magnetic resonance imaging are still imprecise in identifying surgically confirmed residual disease after neoadjuvant chemotherapy (10,11) and the sensitivity and specificity of these imaging techniques vary markedly, (12) so surgery remains the most reliable method of detecting any residual disease.
The aims of this study are
- to evaluate the ability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) to identify residual breast disease in breast cancer patients with either complete clinical/radiological complete response or with residual disease <1 cm after systemic neoadjuvant treatment; and
- to evaluate the ability of biopsy to identify residual axillary lymph node disease in patients who are cN1 pre-treatment and whose suspicious nodes are marked with a metal clip before treatment.
The VAB/needle biopsy results will be compared to pathological findings after quadrantectomy/mastectomy or surgical removal of the sentinel axillary lymph node(s) and tagged axillary lymph node(s) (if distinct from the sentinel node(s)).
This study is being conducted with a view to performing a future clinical trial on the omission of surgery in cases with clinical/radiological complete response and negative preoperative VAB.
- Conditions
- Breast Cancer
- Being tested
- minimally invasive preoperative image-guided vacuum-assisted biopsy
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, vacuum-assisted biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive preoperative image-guided vacuum-assisted biopsyDevice
Also called needle biopsy
minimally invasive preoperative image-guided vacuum-assisted biopsy of the breast and needle biopsy of axillary lymph node
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive preoperative image-guided vacuum-assisted biopsy | cT1-cT2-cT3 cN0-cN1 breast cancer patients, either with clinical/radiological complete response, or with <1 cm residual breast disease after systemic primary treatment, undergo preoperative image-guided breast VAB with 9-gauge needle.
Patients who are cN1 before systemic primary treatment undergo removal of the tagged axillary nodes.
In both cases the aim is to identify any residual disease. Conservative breast surgery or mastectomy will be performed in all patients after multidisciplinary clinical evaluation.
Surgically confirmed residual tumor will be compared to VAB result. Receives: Device: minimally invasive preoperative image-guided vacuum-assisted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery
Identification of percentage of cases with correspondence between pre-operative VAB findings in breast with histological findings after quadrantectomy or mastectomy in patients with complete radiological response after neoadjuvant chemotherapy.
Measured: 40 days
Secondary outcomes (1)
Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery
Identification of percentage of cases with correspondence between pre-operative biopsy findings in tagged cN1 axillary lymph nodes with histological findings after sentinel node biopsy and surgical removal of the tagged node/s (if different from the sentinel node(s)).
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start28 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Martelli, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951699
- Sponsor's protocol ID
- INT 198/21
- Status last verified
- May 2023
- First submitted
- 1 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bonadonna G, Veronesi U, Brambilla C, Ferrari L, Luini A, Greco M, Bartoli C, Coopmans de Yoldi G, Zucali R, Rilke F, et al. Primary chemotherapy to avoid mastectomy in tumors with diameters of three centimeters or more. J Natl Cancer Inst. 1990 Oct 3;82(19):1539-45. doi: 10.1093/jnci/82.19.1539.
PubMed 2402015Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
PubMed 9215816Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200/JCO.2011.39.2779. Epub 2012 May 29.
PubMed 22649152Shin HC, Han W, Moon HG, Im SA, Moon WK, Park IA, Park SJ, Noh DY. Breast-conserving surgery after tumor downstaging by neoadjuvant chemotherapy is oncologically safe for stage III breast cancer patients. Ann Surg Oncol. 2013 Aug;20(8):2582-9. doi: 10.1245/s10434-013-2909-6. Epub 2013 Mar 16.
PubMed 23504119von 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 22508812Martelli G, Miceli R, Folli S, Guzzetti E, Chifu C, Maugeri I, Ferranti C, Bianchi G, Capri G, Carcangiu ML, Paolini B, Agresti R, Ferraris C, Piromalli D, Greco M. Sentinel node biopsy after primary chemotherapy in cT2 N0/1 breast cancer patients: Long-term results of a retrospective study. Eur J Surg Oncol. 2017 Nov;43(11):2012-2020. doi: 10.1016/j.ejso.2017.07.023. Epub 2017 Aug 10.
PubMed 28912071Haque W, Verma V, Hatch S, Suzanne Klimberg V, Brian Butler E, Teh BS. Response rates and pathologic complete response by breast cancer molecular subtype following neoadjuvant chemotherapy. Breast Cancer Res Treat. 2018 Aug;170(3):559-567. doi: 10.1007/s10549-018-4801-3. Epub 2018 Apr 24.
PubMed 29693228Goorts B, van Nijnatten TJ, de Munck L, Moossdorff M, Heuts EM, de Boer M, Lobbes MB, Smidt ML. Clinical tumor stage is the most important predictor of pathological complete response rate after neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2017 May;163(1):83-91. doi: 10.1007/s10549-017-4155-2. Epub 2017 Feb 15.
PubMed 28205044Santonja A, Sanchez-Munoz A, Lluch A, Chica-Parrado MR, Albanell J, Chacon JI, Antolin S, Jerez JM, de la Haba J, de Luque V, Fernandez-De Sousa CE, Vicioso L, Plata Y, Ramirez-Tortosa CL, Alvarez M, Llacer C, Zarcos-Pedrinaci I, Carrasco E, Caballero R, Martin M, Alba E. Triple negative breast cancer subtypes and pathologic complete response rate to neoadjuvant chemotherapy. Oncotarget. 2018 May 29;9(41):26406-26416. doi: 10.18632/oncotarget.25413. eCollection 2018 May 29.
PubMed 29899867Chagpar AB, Middleton LP, Sahin AA, Dempsey P, Buzdar AU, Mirza AN, Ames FC, Babiera GV, Feig BW, Hunt KK, Kuerer HM, Meric-Bernstam F, Ross MI, Singletary SE. Accuracy of physical examination, ultrasonography, and mammography in predicting residual pathologic tumor size in patients treated with neoadjuvant chemotherapy. Ann Surg. 2006 Feb;243(2):257-64. doi: 10.1097/01.sla.0000197714.14318.6f.
PubMed 16432360Croshaw R, Shapiro-Wright H, Svensson E, Erb K, Julian T. Accuracy of clinical examination, digital mammogram, ultrasound, and MRI in determining postneoadjuvant pathologic tumor response in operable breast cancer patients. Ann Surg Oncol. 2011 Oct;18(11):3160-3. doi: 10.1245/s10434-011-1919-5. Epub 2011 Sep 27.
PubMed 21947594Fowler AM, Mankoff DA, Joe BN. Imaging Neoadjuvant Therapy Response in Breast Cancer. Radiology. 2017 Nov;285(2):358-375. doi: 10.1148/radiol.2017170180.
PubMed 29045232Heil J, Pfob A, Sinn HP, Rauch G, Bach P, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Ditsch N, Rody A, Grosse R, van Mackelenbergh M, Reinisch M, Karsten M, Golatta M; RESPONDER Investigators. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number GS5-03. Ann Surg. 2022 Mar 1;275(3):576-581. doi: 10.1097/SLA.0000000000004246.
PubMed 32657944Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
PubMed 8870764
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial to Assess a Mini-invasive Pre-surgical Procedure to Detect Residual Breast or Axillary Disease in Patients With cT1-T2-T3 cN0/N1 Breast Cancer in Complete Clinical/Radiological Remission After Primary Chemotherapy
- ClinicalTrials.gov ID
- NCT05951699
- Acronym / sponsor ID
- INT 198/21
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, vacuum-assisted biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jul 2023 (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.
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease.
The aims of this study are:
- To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
- To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment.
After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip.
The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.
Detailed description
Systemic neoadjuvant treatment was introduced in the 1990s (1,2) mainly for advanced (cT2, cT3) breast cancer to reduce the extent of disease and hence allow conservative surgery instead of mastectomy.
Studies (3-6) demonstrated that pathologic complete response (pCR) in the breast and/or axilla after neoadjuvant treatment predicted better overall survival (OS), better distant relapse-free survival (DRS), and lower mortality.
More recently, targeted neoadjuvant therapies achieve pCR in over 60% of patients (7,8) and in up to 70% of patients with HER2-positive or triple negative subtypes that are generally associated with poorer outcomes (9).
Ultrasound, mammography and magnetic resonance imaging are still imprecise in identifying surgically confirmed residual disease after neoadjuvant chemotherapy (10,11) and the sensitivity and specificity of these imaging techniques vary markedly, (12) so surgery remains the most reliable method of detecting any residual disease.
The aims of this study are
- to evaluate the ability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) to identify residual breast disease in breast cancer patients with either complete clinical/radiological complete response or with residual disease <1 cm after systemic neoadjuvant treatment; and
- to evaluate the ability of biopsy to identify residual axillary lymph node disease in patients who are cN1 pre-treatment and whose suspicious nodes are marked with a metal clip before treatment.
The VAB/needle biopsy results will be compared to pathological findings after quadrantectomy/mastectomy or surgical removal of the sentinel axillary lymph node(s) and tagged axillary lymph node(s) (if distinct from the sentinel node(s)).
This study is being conducted with a view to performing a future clinical trial on the omission of surgery in cases with clinical/radiological complete response and negative preoperative VAB.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| minimally invasive preoperative image-guided vacuum-assisted biopsy | – | Device: minimally invasive preoperative image-guided vacuum-assisted biopsycT1-cT2-cT3 cN0-cN1 breast cancer patients, either with clinical/radiological complete response, or with <1 cm residual breast disease after systemic primary treatment, undergo preoperative image-guided breast VAB with 9-gauge needle. Patients who are cN1 before systemic primary treatment undergo removal of the tagged axillary nodes. In both cases the aim is to identify any residual disease. Conservative breast surgery or mastectomy will be performed in all patients after multidisciplinary clinical evaluation. Surgically confirmed residual tumor will be compared to VAB result. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cT1-cT2-cT3 cN0-cN1 breast cancer patients, either with clinical/radiological complete response, or with <1 cm residual breast disease after systemic primary treatment
Key inclusion criteria (5 listed)
- Radiologically confirmed unifocal cT1-cT2-cT3 cN0-cN1 breast cancer patients indicated for primary chemotherapy
- Histologically confirmed HER2-positive, triple negative or luminal B HER2-positive invasive breast cancer
- Clinical/radiological complete response or residual breast disease <1 cm after primary chemotherapy
- Absence of locoregional relapse or distant metastasis
- Signed informed consent to participate.
Key exclusion criteria (2 listed)
- Disease surgically inoperable or surgery not performed
- Multifocal disease or presence of microcalcifications at imaging.
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 |
|---|---|---|
| minimally invasive preoperative image-guided vacuum-assisted biopsyAlso: needle biopsyminimally invasive preoperative image-guided vacuum-assisted biopsy of the breast and needle biopsy of axillary lymph node | Device | minimally invasive preoperative image-guided vacuum-assisted biopsy |
Primary outcome
Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery
Time frame: 40 days
Identification of percentage of cases with correspondence between pre-operative VAB findings in breast with histological findings after quadrantectomy or mastectomy in patients with complete radiological response after neoadjuvant chemotherapy.
1 secondary outcome
Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery
Time frame: 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Results publication: PubMed 2402015Bonadonna G, Veronesi U, Brambilla C, Ferrari L, Luini A, Greco M, Bartoli C, Coopmans de Yoldi G, Zucali R, Rilke F, et al. Primary chemotherapy to avoid mastectomy in tumors with diameters of three centimeters or more. J Natl Cancer Inst. 1990 Oct 3;82(19):1539-45. doi: 10.1093/jnci/82.19.1539.
- Results publication: PubMed 9215816Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
- Results publication: PubMed 22649152Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200/JCO.2011.39.2779. Epub 2012 May 29.
- Results publication: PubMed 23504119Shin HC, Han W, Moon HG, Im SA, Moon WK, Park IA, Park SJ, Noh DY. Breast-conserving surgery after tumor downstaging by neoadjuvant chemotherapy is oncologically safe for stage III breast cancer patients. Ann Surg Oncol. 2013 Aug;20(8):2582-9. doi: 10.1245/s10434-013-2909-6. Epub 2013 Mar 16.
- Results publication: 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.
- Results publication: PubMed 28912071Martelli G, Miceli R, Folli S, Guzzetti E, Chifu C, Maugeri I, Ferranti C, Bianchi G, Capri G, Carcangiu ML, Paolini B, Agresti R, Ferraris C, Piromalli D, Greco M. Sentinel node biopsy after primary chemotherapy in cT2 N0/1 breast cancer patients: Long-term results of a retrospective study. Eur J Surg Oncol. 2017 Nov;43(11):2012-2020. doi: 10.1016/j.ejso.2017.07.023. Epub 2017 Aug 10.
- Results publication: PubMed 29693228Haque W, Verma V, Hatch S, Suzanne Klimberg V, Brian Butler E, Teh BS. Response rates and pathologic complete response by breast cancer molecular subtype following neoadjuvant chemotherapy. Breast Cancer Res Treat. 2018 Aug;170(3):559-567. doi: 10.1007/s10549-018-4801-3. Epub 2018 Apr 24.
- Results publication: PubMed 28205044Goorts B, van Nijnatten TJ, de Munck L, Moossdorff M, Heuts EM, de Boer M, Lobbes MB, Smidt ML. Clinical tumor stage is the most important predictor of pathological complete response rate after neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2017 May;163(1):83-91. doi: 10.1007/s10549-017-4155-2. Epub 2017 Feb 15.
- Results publication: PubMed 29899867Santonja A, Sanchez-Munoz A, Lluch A, Chica-Parrado MR, Albanell J, Chacon JI, Antolin S, Jerez JM, de la Haba J, de Luque V, Fernandez-De Sousa CE, Vicioso L, Plata Y, Ramirez-Tortosa CL, Alvarez M, Llacer C, Zarcos-Pedrinaci I, Carrasco E, Caballero R, Martin M, Alba E. Triple negative breast cancer subtypes and pathologic complete response rate to neoadjuvant chemotherapy. Oncotarget. 2018 May 29;9(41):26406-26416. doi: 10.18632/oncotarget.25413. eCollection 2018 May 29.
- Results publication: PubMed 16432360Chagpar AB, Middleton LP, Sahin AA, Dempsey P, Buzdar AU, Mirza AN, Ames FC, Babiera GV, Feig BW, Hunt KK, Kuerer HM, Meric-Bernstam F, Ross MI, Singletary SE. Accuracy of physical examination, ultrasonography, and mammography in predicting residual pathologic tumor size in patients treated with neoadjuvant chemotherapy. Ann Surg. 2006 Feb;243(2):257-64. doi: 10.1097/01.sla.0000197714.14318.6f.
- Results publication: PubMed 21947594Croshaw R, Shapiro-Wright H, Svensson E, Erb K, Julian T. Accuracy of clinical examination, digital mammogram, ultrasound, and MRI in determining postneoadjuvant pathologic tumor response in operable breast cancer patients. Ann Surg Oncol. 2011 Oct;18(11):3160-3. doi: 10.1245/s10434-011-1919-5. Epub 2011 Sep 27.
- Results publication: PubMed 29045232Fowler AM, Mankoff DA, Joe BN. Imaging Neoadjuvant Therapy Response in Breast Cancer. Radiology. 2017 Nov;285(2):358-375. doi: 10.1148/radiol.2017170180.
- Individual participant dataSharing planned: Undecided
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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.
Gabriele Martelli, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy
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, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Martelli, MD (+39 02 2390 3436, gabriele.martelli@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery (time frame: 40 days). 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 NCT05951699, which also lists 14 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 19 Jul 2023.