Mathematical Modeling to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03983538

Run by

New Mexico Cancer Research Alliance

People needed

10

Starts

2015-06-02

Expected to finish

2018-01-28

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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
• 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)

Where it is running

• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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