Breast CancerNCT03983538
Mathematical Modeling to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer
An observational study of Breast Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant anthracycline / taxane based chemotherapy in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mathematical modeling to predict response to chemotherapy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2015to 28 Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Stage II-III HER2 negative breast cancer who are candidates for neoadjuvant anthracycline / taxane based chemotherapy
Who may be able to join
- Women with newly diagnosed human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor (ER) positive or negative, progesterone receptor (PR) positive or negative infiltrating ductal carcinoma (IDC) of the breast
- Clinically stage II-III
- Patients with inflammatory, multifocal, multicentric and synchronous bilateral breast cancers are allowed. However, in patients with inflammatory breast cancer, patients must have a measurable, biopsied mass within the breast pre-chemotherapy.
- Willing and able to provide informed consent
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
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- Patients must be able to receive neoadjuvant anthracycline / taxane based chemotherapy in the opinion of the treating physician. Criteria include:
- Adequate bone marrow function, as defined by peripheral granulocyte count of ≥ 1,500/mm3, and platelet count ≥100,000/mm3
- Adequate renal function with creatinine levels ≤ 1.5 X the upper limit of normal and estimated glomerular filtration rate (eGFR) >30.
- Adequate liver function with a bilirubin, Alkaline phosphatase and transaminases (ALT and AST) of ≤ 1.5 X the institutional upper limit of normal.
- Multigated acquisition (MUGA) or echocardiogram (ECHO) demonstrating a left ventricular ejection fraction (LVEF) within institutional normal limits
- Women of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients may also co-enroll in trials that compare local therapies, or compare systemic adjuvant therapies.
- Patients must have had (or be scheduled to have) a pre neoadjuvant chemotherapy MRI of the breast with gadolinium contrast as part of their planned routine breast cancer care.
Who cannot join
- Patients must not have had surgery or radiation or begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
- Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen.
- Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI.
- History of severe claustrophobia
- History of allergic reaction to gadolinium
- Patients must not have metastatic disease
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- Baseline sensory/motor neuropathy > grade 2
- Clinically significant cardiovascular disease
- Serious intercurrent infection or nonmalignant medical illness
- Creatinine clearance prohibiting the use of gadolinium (eGFR < 30)
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: A Single Center Pilot Study Evaluating the Use of Mathematical Modeling to Predict Response to Neoadjuvant Anthracycline / Taxane Based Chemotherapy in Women With HER2 Negative Stage II and III Breast Cancer
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant anthracycline / taxane based chemotherapy in patients with breast cancer.
Read the detailed description
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant chemotherapy in patients with breast cancer. Chemotherapy will be protocol-approved chemotherapy regimen containing intravenous Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel).
Patients receive a protocol-approved chemotherapy regimen containing Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel) based on the patient and/or physician preference.
Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy.
Following the completion of neoadjuvant chemotherapy, surgical approach and adjuvant radiation and endocrine therapy are left to the discretion of the treating physicians.
- Conditions
- Breast Cancer
- Being tested
- Mathematical modeling to predict response to chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mathematical modeling to predict response to chemotherapyOther
Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving chemotherapy | Patients receive a protocol-approved chemotherapy regimen containing Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel) based on the patient and/or physician preference. Receives: Other: Mathematical modeling to predict response to chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path in women with breast cancer undergoing neoadjuvant chemotherapy
To assess the feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path (fraction of tumor cells killed calculated using data obtained from histopathology) in 10 women with stage II-III Her2-negative, Estrogen Receptor (ER) positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy.
Calculation of patient specific distribution of liver portal radii or characteristic vessel radius (rb), BVF, and the distance that drugs diffuse through tumor tissue (L) and ƒkill-path (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy hematoxylin and eosin (H and E) stained section of diagnostic needle core biopsy specimen. Feasibility of the primary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Measured: 5 years
Feasibility of calculating tumor BVF from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant chemotherapy
To assess the feasibility of calculating patient specific fraction of blood volume within the tumor (tumor BVF) using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy.
Calculation of patient specific BVF (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Measured: 5 years
Feasibility of calculating ƒkill-rad from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant anthracycline / taxane based chemotherapy
To assess the feasibility of calculating patient specific fraction of tumor cells killed using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy.
Calculation of patient specific ƒkill-rad (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Measured: 5 years
Secondary outcomes (2)
Association between ƒkill-path and ƒkill-rad as calculated with the investigator's mathematical model and response to neoadjuvant chemotherapy at the time of surgery
To evaluate the association between fraction of tumor cells killed using data obtained from histopathology (ƒkill-path) and ƒkill-rad as calculated with the investigators' mathematical model and response to neoadjuvant chemotherapy at the time of surgery.
The secondary endpoint for describing the association between ƒkillpath and ƒkill-rad is the Spearman correlation coefficient between the two. Endpoints for describing the association between ƒkill-path or ƒkillrad and response will be the mean (SD) and median (Q1-Q3) of ƒkillpath and ƒkill-rad for responders and non-responders. Response will be defined by 1) complete pathologic response (pCR) within the breast and 2) pCR and/or CPS+ EG score < 2 (3).
Measured: 5 years
Association between ƒkill-path and ƒkill-rad and biomarkers as calculated with a mathematical model
To evaluate the association between ƒkill-path and ƒkill-rad as calculated with the investigators' mathematical model and biomarkers associated with tumor angiogenesis, metabolism, acid-base regulation, stress response and invasion.
The secondary endpoints for describing the association between ƒkill-path and ƒkill-rad and biomarkers associated with tumor angiogenesis, metabolism, acid-base regulation, stress response and invasion are the Spearman correlation coefficients for continuous biomarker measures, or means (SD) and medians (Q1-Q3) of ƒkill-path and ƒkill-rad by levels of categorical biomarkers.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start2 Jun 2015
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursa Brown-Glaberman, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983538
- Sponsor's protocol ID
- INST 1411
- Status last verified
- May 2021
- First submitted
- 4 Jun 2019
- Last updated
- 12 May 2021
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Study Evaluating the Use of Mathematical Modeling to Predict Response to Neoadjuvant Anthracycline / Taxane Based Chemotherapy in Women With HER2 Negative Stage II and III Breast Cancer
- ClinicalTrials.gov ID
- NCT03983538
- Acronym / sponsor ID
- INST 1411
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 12 Jun 2019 (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.
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant anthracycline / taxane based chemotherapy in patients with breast cancer.
Detailed description
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant chemotherapy in patients with breast cancer. Chemotherapy will be protocol-approved chemotherapy regimen containing intravenous Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel).
Patients receive a protocol-approved chemotherapy regimen containing Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel) based on the patient and/or physician preference.
Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy.
Following the completion of neoadjuvant chemotherapy, surgical approach and adjuvant radiation and endocrine therapy are left to the discretion of the treating physicians.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving chemotherapy | – | Other: Mathematical modeling to predict response to chemotherapyPatients receive a protocol-approved chemotherapy regimen containing Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel) based on the patient and/or physician preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Stage II-III HER2 negative breast cancer who are candidates for neoadjuvant anthracycline / taxane based chemotherapy
Key inclusion criteria (14 listed)
- Women with newly diagnosed human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor (ER) positive or negative, progesterone receptor (PR) positive or negative infiltrating ductal carcinoma (IDC) of the breast
- Clinically stage II-III
- Patients with inflammatory, multifocal, multicentric and synchronous bilateral breast cancers are allowed. However, in patients with inflammatory breast cancer, patients must have a measurable, biopsied mass within the breast pre-chemotherapy.
- Willing and able to provide informed consent
- Age ≥ 18 years.
Key exclusion criteria (10 listed)
- Patients must not have had surgery or radiation or begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
- Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen.
- Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI.
- History of severe claustrophobia
- History of allergic reaction to gadolinium
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 |
|---|---|---|
| Mathematical modeling to predict response to chemotherapyMathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy. | Other | Patients receiving chemotherapy |
Primary outcome
Feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path in women with breast cancer undergoing neoadjuvant chemotherapy
Time frame: 5 years
To assess the feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path (fraction of tumor cells killed calculated using data obtained from histopathology) in 10 women with stage II-III Her2-negative, Estrogen Receptor (ER) positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific distribution of liver portal radii or characteristic vessel radius (rb), BVF, and the distance that drugs diffuse through tumor tissue (L) and ƒkill-path (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy hematoxylin and eosin (H and E) stained section of diagnostic needle core biopsy specimen. Feasibility of the primary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Feasibility of calculating tumor BVF from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant chemotherapy
Time frame: 5 years
To assess the feasibility of calculating patient specific fraction of blood volume within the tumor (tumor BVF) using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific BVF (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Feasibility of calculating ƒkill-rad from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant anthracycline / taxane based chemotherapy
Time frame: 5 years
To assess the feasibility of calculating patient specific fraction of tumor cells killed using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific ƒkill-rad (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
2 secondary outcomes
Association between ƒkill-path and ƒkill-rad as calculated with the investigator's mathematical model and response to neoadjuvant chemotherapy at the time of surgery
Time frame: 5 years
Association between ƒkill-path and ƒkill-rad and biomarkers as calculated with a mathematical model
Time frame: 5 years
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 12 May 2021.
- 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.
Ursa Brown-Glaberman, MD principal investigator
University of New Mexico 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 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 14 inclusion and 10 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 12 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 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?
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?
Feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path in women with breast cancer undergoing neoadjuvant chemotherapy (time frame: 5 years). The study lists 3 primary outcomes in all. 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 12 May 2021.