Breast CancerMIBPBPCRNCT03789851
Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer
A study testing core needle biopsy in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NAC and targeted therapies, there has been dramatic improvement in pCR rates, especially among triple-negative and human… 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
- What is being tested?
- core needle biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol
- with cT1c-cT4a-c tumors
- after informed consent
- with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
- Clinical / imaging partial or complete response to NAC
- Any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
Show all 9Show fewer
- Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
- Inclusion of only one breast per patient, in bilateral cancer one breast can be included
- In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.
Who cannot join
- Palliative or recurrent breast cancer
- Pregnancy and lactation
- cT4d stage (inflammatory breast cancer)
- M1 stages
- stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
- dislocation of marker (> 10mm distance to the initial lesion)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University
Jinan, 250117
Yong-sheng Wang, +86 676-26213, wangysh2008@aliyun.com
About this study
Official title: Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer
Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NAC and targeted therapies, there has been dramatic improvement in pCR rates, especially among triple-negative and human epidermal growth factor receptor 2 positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher. NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer, and the need for breast surgery in NAC cases with pCR has been questioned, especially in patients undergoing breast-conserving surgery with whole breast radiotherapy. The main impediments for potential elimination of breast surgery have been the fact that conventional and functional breast imaging techniques are incapable of accurate prediction of residual disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the potential to overcome this impediment.
The investigators design and begin a prospective one-armed clinical study to explore the accuracy of MIB in predicting breast pCR after NAC.
Read the detailed description
In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. However, up to now, prediction of pCR after NACT is only moderately accurate. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
From June 1st, 2017 to June 15th, 2019 the investigators performed ultrasound-guided multipoint core needle biopsy (CNB) on 50 breast cancer patients after NAC and directly after surgery. To analyse CNB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.
- Conditions
- Breast Cancer
- Being tested
- core needle 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.
core needle biopsyDevice
Also called ultrasound-guided multipoint core needle biopsy
Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.
| Study group | Role | What they receive |
|---|---|---|
| core needle biopsy | Experimental | All patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery. Receives: Device: core needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
false negative CNB results，reported as the false negative rate (= FNR)
non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
Measured: after breast surgery, up to 2 weeks after CNB
Secondary outcomes (1)
negative predictive value (NPV)
The negative predictive value (NPV) will be calculated as the quotient of the number of cases with pCR in CNB and in surgical specimen (= true negative result), divided by the total number of cases with pCR in CNB. Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
Measured: after breast surgery, up to 2 weeks after CNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jun 2017
- Primary completion15 Jun 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789851
- Sponsor's protocol ID
- MIB001
- Acronym
- MIBPBPCR
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT03789851
- Acronym / sponsor ID
- MIBPBPCR / MIB001
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 31 Dec 2018 (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.
Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NAC and targeted therapies, there has been dramatic improvement in pCR rates, especially among triple-negative and human epidermal growth factor receptor 2 positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher. NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer, and the need for breast surgery in NAC cases with pCR has been questioned, especially in patients undergoing breast-conserving surgery with whole breast radiotherapy. The main impediments for potential elimination of breast surgery have been the fact that conventional and functional breast imaging techniques are incapable of accurate prediction of residual disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the potential to overcome this impediment.
The investigators design and begin a prospective one-armed clinical study to explore the accuracy of MIB in predicting breast pCR after NAC.
Detailed description
In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. However, up to now, prediction of pCR after NACT is only moderately accurate. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
From June 1st, 2017 to June 15th, 2019 the investigators performed ultrasound-guided multipoint core needle biopsy (CNB) on 50 breast cancer patients after NAC and directly after surgery. To analyse CNB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| core needle biopsy | Experimental | Device: core needle biopsyAll patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol
- with cT1c-cT4a-c tumors
- after informed consent
- with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
- Clinical / imaging partial or complete response to NAC
Key exclusion criteria (6 listed)
- Palliative or recurrent breast cancer
- Pregnancy and lactation
- cT4d stage (inflammatory breast cancer)
- M1 stages
- stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
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 |
|---|---|---|
| core needle biopsyAlso: ultrasound-guided multipoint core needle biopsyBecause the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area. | Device | core needle biopsy |
Primary outcome
false negative CNB results，reported as the false negative rate (= FNR)
Time frame: after breast surgery, up to 2 weeks after CNB
non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
1 secondary outcome
negative predictive value (NPV)
Time frame: after breast surgery, up to 2 weeks after CNB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core needle biopsy in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
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 9 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 31 Dec 2018. 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 China. 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 Yong-sheng Wang (+86 0531-67626213, wangysh2008@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
false negative CNB results，reported as the false negative rate (= FNR) (time frame: after breast surgery, up to 2 weeks after CNB). 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 31 Dec 2018.