Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female PatientsNCT01984866
CPR Prediction After Neoadjuvant Using Excisional Biopsy By Radiofrequency In Breast Cancer From II-III UICC Stages.
An observational study of Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female Patients, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
This project aims to determine whether biopsy using radiofrequency is a procedure suitable for this patient selection. Findings from biopsy will be correlated with the conventional surgery ones. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female Patients
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Aug 2018
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with breast tumors sensitive to neoadjuvancy
Who may be able to join
- Informed consent Form signed
- Adequate Performance status (ECOG 0-1)
- Female patients with unifocal breast tumors (stages II-III, TN, HER2+ or Luminal B) very sensitive to neoadjuvant medical treatment (5 to 6 months in accordance with the current standard)
- Patients who submit clinical-radiologic greater response to the treatment administered (equal to or less than 1.5 cm in NMR residual tumor)
Who cannot join
- Ki67<14%
- Excisional biopsy Contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complete Pathological Response Prediction After Neoadjuvant Treatment Using Excisional Biopsy By Radiofrequency In Breast Cancer From II-III UICC Stages.
This project aims to determine whether biopsy using radiofrequency is a procedure suitable for this patient selection. Findings from biopsy will be correlated with the conventional surgery ones. If the technique is validated to predict the presence or absence of residual tumor, breast surgery could be avoided in cases of absence of tumor.
Read the detailed description
Breast cancer is a set of at least 4 different diseases, currently known as intrinsic genomic subtypes. Two of them are the so-called HER2-enriched, characterized by the HER-2 oncogene amplification, and the basal-like, which correlates closely with some of the triple negative tumors (TNBC). These subtypes are very sensitive to the primary medical treatment (neoadjuvant or Presurgical). The use of modern medical treatments as initial treatment, can allow the complete disappearance of cancer in the breast and axilla (pathologic complete response, CPR) in 40% of patients with TNBC and around 60% of patients with HER2-positive tumors in stage II and III.
The need of local surgery in patients where the tumor disappeared completely (CPR) after primary medical treatment, is recently questioned, the improvement is not clear and radiotherapy could be sufficient to assure the locoregional disease control.
The use of conventional diagnostic techniques (MRI, ultrasound, mammography and PET) is not enough reliable to determine the pathological complete response, making difficult to adopt an attitude of surgical abstention. The existence of a minimally invasive technique that could reliably determine the absence of cancer after primary medical treatment surgery, could avoid the surgery in these cases.
Percutaneous biopsy guided by ultrasound radiofrequency is a technique that allows the complete resection of breast lesions up to 2 cm of diameter with minimal aggression to the mammary gland from the area of the initial tumor after the neoadjuvant treatment.
Several studies report the use of this technique in patients with breast cancer. Results show a good tolerability of the technique by the patients and suggest that it would not only reduce the need of the re-excision, but also reduce the rate of local recurrence due to radiation absence.
Biopsy using radiofrequency could be useful to confirm CPR in patients with triple-negative and HER2-positive tumors and several luminal B tumors and good response previously determined by conventional methods (MR in particular). Despite that, new prospective studies to analyse the reliability in patients selection with CPR and could avoid the traditional surgery are needed.
To confirm this hypothesis, a group of 100 treated patients with unicentered tumors in stages II or III and good response determined by MR after 6 cycles of treatment (less than 2 cm apparent residual injury) will be consecutively subjected to radiofrequency biopsy and the surgery previously established for each case (Tumorectomy or mastectomy). Before surgery, the sentinel node will be biopsied in order to define the surgical treatment on the axilla (none in case of negative sentinel node, axillary lymphadenectomy if positive).
The tumor samples obtained by percutaneous radiofrequency and mastectomy-Tumorectomy biopsy will be studied thoroughly to define the correlation between the two.
- Keywords
- CPR: Complete Pathological Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast tumors sensitive to neoadjuvant | Treated patients as usual clinical practice with unicentered tumors in stages II or III and good response determined by MR after 6 cycles of treatment (less than 2 cm apparent residual injury) will be consecutively subjected to radiofrequency biopsy and the surgery previously established for each case (Tumorectomy or mastectomy). Before surgery, the sentinel node will be biopsied in order to define the surgical treatment on the axilla (none in case of negative sentinel node, axillary lymphadenectomy if positive). The tumor samples obtained by percutaneous radiofrequency and mastectomy-Tumorectomy biopsy will be studied thoroughly to define the correlation between the two. |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of the negative predictive value (NPV) of the excisional biopsy technique
Proportion of biopsies which PCR, are really PCR in the surgical specimen.
Measured: up to 15 months
Secondary outcomes (1)
Evaluation of sensitivity and specificity of the excisional biopsy by radiofrequency technique
- Determine the sensitivity and specificity of excisional biopsy, radiofrequency technique, to classify correctly the stage of the tumor in the breast after neoadjuvant therapy.
- Determine the positive predictive value (proportion of biopsies which are not CPR and actually have tumor in the surgical specimen).
- Describe the side effects of the excisional biopsy technique by radiofrequency.
- Describe the technical problems associated to excisional biopsy technique by radiofrequency.
- Assess the concordance between the responses obtained in breast MRI and the previous reported in the anatomy-pathological study.
- Determine the % of cases in which surgery could have been avoided within the group defined in the study.
- Estimate the economic cost of excisional biopsy with standard therapy
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2018
- Study completionAug 2018
Why it stopped: Recruitment was very low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female PatientsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984866
- Sponsor's protocol ID
- GOMHGUGM032012
- Status last verified
- Aug 2020
- First submitted
- 10 Oct 2013
- Last updated
- 11 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Pathological Response Prediction After Neoadjuvant Treatment Using Excisional Biopsy By Radiofrequency In Breast Cancer From II-III UICC Stages.
- ClinicalTrials.gov ID
- NCT01984866
- Acronym / sponsor ID
- GOMHGUGM032012
- Keywords
- CPR: Complete Pathological Response
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment was very low.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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.
This project aims to determine whether biopsy using radiofrequency is a procedure suitable for this patient selection. Findings from biopsy will be correlated with the conventional surgery ones. If the technique is validated to predict the presence or absence of residual tumor, breast surgery could be avoided in cases of absence of tumor.
Detailed description
Breast cancer is a set of at least 4 different diseases, currently known as intrinsic genomic subtypes. Two of them are the so-called HER2-enriched, characterized by the HER-2 oncogene amplification, and the basal-like, which correlates closely with some of the triple negative tumors (TNBC). These subtypes are very sensitive to the primary medical treatment (neoadjuvant or Presurgical). The use of modern medical treatments as initial treatment, can allow the complete disappearance of cancer in the breast and axilla (pathologic complete response, CPR) in 40% of patients with TNBC and around 60% of patients with HER2-positive tumors in stage II and III.
The need of local surgery in patients where the tumor disappeared completely (CPR) after primary medical treatment, is recently questioned, the improvement is not clear and radiotherapy could be sufficient to assure the locoregional disease control.
The use of conventional diagnostic techniques (MRI, ultrasound, mammography and PET) is not enough reliable to determine the pathological complete response, making difficult to adopt an attitude of surgical abstention. The existence of a minimally invasive technique that could reliably determine the absence of cancer after primary medical treatment surgery, could avoid the surgery in these cases.
Percutaneous biopsy guided by ultrasound radiofrequency is a technique that allows the complete resection of breast lesions up to 2 cm of diameter with minimal aggression to the mammary gland from the area of the initial tumor after the neoadjuvant treatment.
Several studies report the use of this technique in patients with breast cancer. Results show a good tolerability of the technique by the patients and suggest that it would not only reduce the need of the re-excision, but also reduce the rate of local recurrence due to radiation absence.
Biopsy using radiofrequency could be useful to confirm CPR in patients with triple-negative and HER2-positive tumors and several luminal B tumors and good response previously determined by conventional methods (MR in particular). Despite that, new prospective studies to analyse the reliability in patients selection with CPR and could avoid the traditional surgery are needed.
To confirm this hypothesis, a group of 100 treated patients with unicentered tumors in stages II or III and good response determined by MR after 6 cycles of treatment (less than 2 cm apparent residual injury) will be consecutively subjected to radiofrequency biopsy and the surgery previously established for each case (Tumorectomy or mastectomy). Before surgery, the sentinel node will be biopsied in order to define the surgical treatment on the axilla (none in case of negative sentinel node, axillary lymphadenectomy if positive).
The tumor samples obtained by percutaneous radiofrequency and mastectomy-Tumorectomy biopsy will be studied thoroughly to define the correlation between the two.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast tumors sensitive to neoadjuvant | – | –Treated patients as usual clinical practice with unicentered tumors in stages II or III and good response determined by MR after 6 cycles of treatment (less than 2 cm apparent residual injury) will be consecutively subjected to radiofrequency biopsy and the surgery previously established for each case (Tumorectomy or mastectomy). Before surgery, the sentinel node will be biopsied in order to define the surgical treatment on the axilla (none in case of negative sentinel node, axillary lymphadenectomy if positive). The tumor samples obtained by percutaneous radiofrequency and mastectomy-Tumorectomy biopsy will be studied thoroughly to define the correlation between the two. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with breast tumors sensitive to neoadjuvancy
Key inclusion criteria (4 listed)
- Informed consent Form signed
- Adequate Performance status (ECOG 0-1)
- Female patients with unifocal breast tumors (stages II-III, TN, HER2+ or Luminal B) very sensitive to neoadjuvant medical treatment (5 to 6 months in accordance with the current standard)
- Patients who submit clinical-radiologic greater response to the treatment administered (equal to or less than 1.5 cm in NMR residual tumor)
Key exclusion criteria (2 listed)
- Ki67<14%
- Excisional biopsy Contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
determination of the negative predictive value (NPV) of the excisional biopsy technique
Time frame: up to 15 months
Proportion of biopsies which PCR, are really PCR in the surgical specimen.
1 secondary outcome
Evaluation of sensitivity and specificity of the excisional biopsy by radiofrequency technique
Time frame: up to 15 months
Results and safety
The study was stopped early (reason given: Recruitment was very low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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 Triple Negative, HER2+, Luminal B Breast Tumors (Stages II-III)in Female Patients, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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: stopped early, as of the sponsor's last update on 11 Aug 2020. 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 Spain. 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 was stopped early (reason given: Recruitment was very low.). Results are not available in the source record.
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?
determination of the negative predictive value (NPV) of the excisional biopsy technique (time frame: up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2020.