HER2 Negative Breast CancerNCT03568448
Monitoring Response to Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer Using High-speed MR Spectroscopic Imaging
An observational study of HER2 Negative Breast Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
The study will assess whether changes in total choline concentration [tCho] during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with HER2 negative breast cancer (HNBC) appropriate for NAC, and compare these findings with dynamic contrast enhanced magnetic resonance… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Negative Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible female breast cancer patients receiving treatment at the University of New Mexico Comprehensive Cancer Center.
Who may be able to join
- Have a biopsy proven HER2 negative (by IHC or FISH) breast cancer per standard clinical criteria (per ASCO-CAP guidelines). Although patients with hormone-receptor positive (ER+ and/or PR+) disease will be included, patients with tumor features indicative of luminal A intrinsic sub-type will be excluded from this study. Excluding features are:
- Patients with Grade 1 breast cancers, as assessed by local standard criteria, will be excluded from participation.
- Patients with strongly ER AND PR positive breast cancer, defined as >75% positive staging for BOTH markers by IHC, will be excluded from participation.
- Stage of disease that is appropriate for standard NAC (any combination of T2 to T4, N0 to N3 that would comprise stage IIA to IIIB disease). Patients with inflammatory carcinoma or stage IIIC disease who are deemed inoperable at the outset, but appropriate for NAC are excluded in this study since there is no guarantee they can be converted to operability following NAC; thus precluding assessment of pCR.
- Medically fit for NAC as per good clinical practice and per the treating physician's judgment.
- Age > or = to 18 years AND able to provide informed consent.
- Women of childbearing potential must be willing and able to use effective means of contraception. A female of childbearing potential is any woman who has not undergone a hysterectomy or bilateral oophorectomy or has not had menses at any time in the preceding 12 consecutive months.
- Able to undergo standard clinical MRI exams PLUS additional 30 minutes longer (total scan time is 50 to 60 minutes).
Who cannot join
- Pregnant or lactating women.
- Body contains foreign items posing an issue of MRI safety, such as intra-ocular metallic foreign bodies, MRI incompatible devices such as pacemakers and cochlear implants, and other MRI incompatible devices.
- Obesity (Body Mass Index [BMI] > 40) or inability to fit into the standard MRI gantry.
- Suffer from back pain, claustrophobia, seizures, panic disorder and/or other medical disorders severe enough that would prevent them from completing a standard clinical MRI study (30 min) + 30 mins for the research scans. If applicable, patients may take a mild anxiolytic (e.g., lorazepam) if deemed appropriate by their treating physician.
- Patients with stage IV disease (gross metastasis or documented M1 disease) and stage of disease excluded above.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
About this study
Official title: Monitoring Response to Neoadjuvant Chemotherapy (NAC) in HER2 Negative Breast Cancer (HNBC) Using High-speed MR Spectroscopic Imaging (MRSI)
The study will assess whether changes in total choline concentration [tCho] during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with HER2 negative breast cancer (HNBC) appropriate for NAC, and compare these findings with dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The objective is to assess the predictive value of changes in the concentration and spatial extent of tCho within the tumor during NAC.
Read the detailed description
The primary objective of the study is to assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC in women with HNBC. The endpoint is the pCR.
Hypothesis 1: Changes in [tCho] early during NAC (from 24 hours after the start of the first cycle until the start of the 2nd cycle of NAC) are predictive of pathologic response (using quantitative metrics of Residual Cancer Burden (RCB)1 and/or CPS+EG score 2 and radiologic response (change in lesion size on DCE-MRI).
Hypothesis 2: Decreases in [tCho] within the tumor precede decreases in tumor volume on DCE-MRI, thus enabling earlier discrimination between responders from non-responders. The primary objective of the study is to assess the correlation of serial high-speed magnetic resonance spectroscopic imaging (MRSI) of [tCho] with pCR following NAC for HNBC. The secondary objective is to compare the time course of [tCho] on serial high-speed MRSI and tumor volume on serial DCE-MRI for predicting early NAC treatment response in HNBC.
Subjects' participation will start approximately 2 weeks before initiation of neoadjuvant therapy and end after surgery.
Patients will undergo up to 5 MRI scans in total as 2 are clinical MRIs and 3 are research scans. The clinical pretreatment MRI scan and a post treatment MRI scan are standard and will be ordered at the discretion of the treating provider.The post treatment MRI is done after clinical response and before surgery. This helps guide the surgeon about what amount of tissue should be removed at surgery. The minimum time between clinical and research MRI scans is 24 hours.
The 3 research MRIs will be performed on a 3T Siemens scanner equipped with 16 channel Hologic breast coil. Breast anatomy will be imaged using a bilateral localizer, an axial T 2-weighted turbo-spin-echo scan, and a fat-suppressed T1-weighted sagittal gradient echo scan. Dynamic non-fat-suppressed T1-weighted axial 3D GRE scans are collected before and with 20s delay at four time points after Gd-HP-DO3A administration (total scan time: 7.5 min). Subtraction images are created using the pre-contrast image as the mask. A diffusion weighted multi-slice EPI scan will be performed to compute apparent diffusion coefficient (ADC) maps online (total scan time: 3:14 min). An axial low-resolution multi-slice multi-echo gradient echo scan will be performed to compute field maps for slice and laterality specific auto-shimming. Spectroscopic imaging will be performed using 3D PEPSI.
The MR measurement protocol will be performed at 3 time points: (1) prior to treatment typically several days before NAC (ideally 24h before NAC) (MRSI, DW-MRI, DCE-MRI), (2) 20-52 hours after the beginning of the first cycle of NAC (MRSI, DW-MRI), and (3) between the first and second cycle of NAC (MRSI, DW-MRI, DCE-MRI).
Surgery will be performed within 3 to 12 weeks of last chemotherapy. RCB will be obtained from the final pathologic findings.
- Conditions
- HER2 Negative Breast Cancer
- Being tested
- Response monitoring (no intervention)
- Keywords
- HER2 negative breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response monitoring (no intervention)Other
Response monitoring (no intervention)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC
In this study changes in total choline concentration [tCho] during neoadjuvant chemotherapy (NAC) will be evaluated by performing a high-speed magnetic resonance spectroscopic imaging (MRSI) at baseline prior to first cycle NAC, after first cycle NAC, and prior to second cycle NAC.
Measured: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
Secondary outcomes (2)
Assess the correlation of serial high-speed MRSI of [tCho] with response to NAC
The endpoint is response as assessed by the validated quantitative metrics of Residual Cancer Burden (RCB) and/or CPS+EG score.
Measured: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
Compare the time course of [tCho] on serial high-speed MRSI and tumor volume on serial DCE-MRI for predicting early NAC treatment response
Outcome measured will be total choline concentration [tCho] as assessed via serial high-speed magnetic resonance spectroscopic imaging (MRSI) .
Measured: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start16 Apr 2018
- Primary completion22 Jan 2020
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Negative 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Posse, PhD, Principal investigator, University of New Mexico Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568448
- Sponsor's protocol ID
- INST 1607
- Status last verified
- May 2025
- First submitted
- 30 May 2018
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Response to Neoadjuvant Chemotherapy (NAC) in HER2 Negative Breast Cancer (HNBC) Using High-speed MR Spectroscopic Imaging (MRSI)
- ClinicalTrials.gov ID
- NCT03568448
- Acronym / sponsor ID
- INST 1607
- Conditions
- HER2 Negative Breast Cancer
- Keywords
- HER2 negative breast cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 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.
The study will assess whether changes in total choline concentration [tCho] during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with HER2 negative breast cancer (HNBC) appropriate for NAC, and compare these findings with dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The objective is to assess the predictive value of changes in the concentration and spatial extent of tCho within the tumor during NAC.
Detailed description
The primary objective of the study is to assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC in women with HNBC. The endpoint is the pCR.
Hypothesis 1: Changes in [tCho] early during NAC (from 24 hours after the start of the first cycle until the start of the 2nd cycle of NAC) are predictive of pathologic response (using quantitative metrics of Residual Cancer Burden (RCB)1 and/or CPS+EG score 2 and radiologic response (change in lesion size on DCE-MRI).
Hypothesis 2: Decreases in [tCho] within the tumor precede decreases in tumor volume on DCE-MRI, thus enabling earlier discrimination between responders from non-responders. The primary objective of the study is to assess the correlation of serial high-speed magnetic resonance spectroscopic imaging (MRSI) of [tCho] with pCR following NAC for HNBC. The secondary objective is to compare the time course of [tCho] on serial high-speed MRSI and tumor volume on serial DCE-MRI for predicting early NAC treatment response in HNBC.
Subjects' participation will start approximately 2 weeks before initiation of neoadjuvant therapy and end after surgery.
Patients will undergo up to 5 MRI scans in total as 2 are clinical MRIs and 3 are research scans. The clinical pretreatment MRI scan and a post treatment MRI scan are standard and will be ordered at the discretion of the treating provider.The post treatment MRI is done after clinical response and before surgery. This helps guide the surgeon about what amount of tissue should be removed at surgery. The minimum time between clinical and research MRI scans is 24 hours.
The 3 research MRIs will be performed on a 3T Siemens scanner equipped with 16 channel Hologic breast coil. Breast anatomy will be imaged using a bilateral localizer, an axial T 2-weighted turbo-spin-echo scan, and a fat-suppressed T1-weighted sagittal gradient echo scan. Dynamic non-fat-suppressed T1-weighted axial 3D GRE scans are collected before and with 20s delay at four time points after Gd-HP-DO3A administration (total scan time: 7.5 min). Subtraction images are created using the pre-contrast image as the mask. A diffusion weighted multi-slice EPI scan will be performed to compute apparent diffusion coefficient (ADC) maps online (total scan time: 3:14 min). An axial low-resolution multi-slice multi-echo gradient echo scan will be performed to compute field maps for slice and laterality specific auto-shimming. Spectroscopic imaging will be performed using 3D PEPSI.
The MR measurement protocol will be performed at 3 time points: (1) prior to treatment typically several days before NAC (ideally 24h before NAC) (MRSI, DW-MRI, DCE-MRI), (2) 20-52 hours after the beginning of the first cycle of NAC (MRSI, DW-MRI), and (3) between the first and second cycle of NAC (MRSI, DW-MRI, DCE-MRI).
Surgery will be performed within 3 to 12 weeks of last chemotherapy. RCB will be obtained from the final pathologic findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible female breast cancer patients receiving treatment at the University of New Mexico Comprehensive Cancer Center.
Key inclusion criteria (8 listed)
- Have a biopsy proven HER2 negative (by IHC or FISH) breast cancer per standard clinical criteria (per ASCO-CAP guidelines). Although patients with hormone-receptor positive (ER+ and/or PR+) disease will be included, patients with tumor features indicative of luminal A intrinsic sub-type will be excluded from this study. Excluding features are:
- Stage of disease that is appropriate for standard NAC (any combination of T2 to T4, N0 to N3 that would comprise stage IIA to IIIB disease). Patients with inflammatory carcinoma or stage IIIC disease who are deemed inoperable at the outset, but appropriate for NAC are excluded in this study since there is no guarantee they can be converted to operability following NAC; thus precluding assessment of pCR.
- Medically fit for NAC as per good clinical practice and per the treating physician's judgment.
- Age > or = to 18 years AND able to provide informed consent.
- Women of childbearing potential must be willing and able to use effective means of contraception. A female of childbearing potential is any woman who has not undergone a hysterectomy or bilateral oophorectomy or has not had menses at any time in the preceding 12 consecutive months.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Body contains foreign items posing an issue of MRI safety, such as intra-ocular metallic foreign bodies, MRI incompatible devices such as pacemakers and cochlear implants, and other MRI incompatible devices.
- Obesity (Body Mass Index [BMI] > 40) or inability to fit into the standard MRI gantry.
- Suffer from back pain, claustrophobia, seizures, panic disorder and/or other medical disorders severe enough that would prevent them from completing a standard clinical MRI study (30 min) + 30 mins for the research scans. If applicable, patients may take a mild anxiolytic (e.g., lorazepam) if deemed appropriate by their treating physician.
- Patients with stage IV disease (gross metastasis or documented M1 disease) and stage of disease excluded above.
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 |
|---|---|---|
| Response monitoring (no intervention)Response monitoring (no intervention) | Other | – |
Primary outcome
Assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC
Time frame: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
In this study changes in total choline concentration [tCho] during neoadjuvant chemotherapy (NAC) will be evaluated by performing a high-speed magnetic resonance spectroscopic imaging (MRSI) at baseline prior to first cycle NAC, after first cycle NAC, and prior to second cycle NAC.
2 secondary outcomes
Assess the correlation of serial high-speed MRSI of [tCho] with response to NAC
Time frame: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
Compare the time course of [tCho] on serial high-speed MRSI and tumor volume on serial DCE-MRI for predicting early NAC treatment response
Time frame: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
Stefan Posse, PhD principal investigator
University of New Mexico Comprehensive Cancer Center
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 HER2 Negative Breast Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess the correlation of serial high-speed MRSI of [tCho] with pCR following NAC (time frame: Patient will begin participation 2 weeks prior to initiation of NAC and will complete participation at the time of surgery, estimated to be 4-6 months total participation duration.). 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 22 May 2025.