Clinical trial NCT02744053: DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
Official title: Multimodality Breast Imaging for the Assessment of Tumor Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Estrogen Receptor Negative
HER2/Neu Negative
Progesterone Receptor Negative
Triple-Negative Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI may help researchers predict which patients may respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the predictive value of advanced imaging modalities Tc99m sestamibi (technetium Tc-99m sestamibi) molecular breast imaging (MBI) and dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) for neoadjuvant chemotherapy (NAC) response in triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. To evaluate and compare the ability all imaging modalities including standard of care digital mammogram (DM) and ultrasound (US) as well as novel modalities DCE-MRI and MBI to assess and predict response to neoadjuvant chemotherapy (NAC) in patients with triple negative breast cancer (TNBC).

EXPLORATORY OBJECTIVES:

I. To determine effect of molecular subtype of TNBC on diagnostic performance of different types of imaging modalities in predicting treatment response.

II. To determine the Utility of Dynamic Tc99m sestamibi MBI and DCE-MRI together with molecular profiling to identify a subgroup of chemoresistant TNBC patients.

OUTLINE:

Patients undergo DCE-MRI over 45-60 minutes. Patients receive technetium Tc-99m sestamibi via injection, and after 5 minutes patients undergo MBI scan over 1 hour. Both DCE-MRI and MBI are performed at the time of enrollment, at the end of anthracycline therapy, and at the conclusion of NAC before surgery. All patients also undergo standard of care imaging with DM and US (at the same time points if the treating doctor chooses to do so).

Eligibility criteria: Inclusion Criteria:

* The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (\< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry \[IHC\] score \< 3, gene copy number not amplified)
* TNBC patients who are previously untreated and enrolled in the prospective Institutional Review Board (IRB) approved clinical trial: 2014-0185
* Patients who are able to understand and give consent to participating in the study

Exclusion Criteria:

* Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
* Has lesions involving chest wall
* Has known allergy to Tc99m sestamibi
* Has known contraindications to MRI
* Has contraindication to MRI contrast

Primary outcomes:
measure: Percent change in volume of index tumors and estimated area under receiver operating characteristic (ROC) curves assessed by digital mammogram, ultrasound, dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and molecular breast imaging (MBI)
timeFrame: Up to 4 years
measure: Percent change in tumor volume assessed by dynamic Tc99m-sestamibi MBI
timeFrame: up to 6 months
measure: Tumor response assessed by pathological examination
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
measure: Utility of molecular breast imaging (MBI) and dynamic contrast enhanced molecular resonance imaging (DCE-MRI) together with molecular profiling to identify a subgroup of chemoresistant triple negative breast cancer (TNBC) patients
timeFrame: up to 6 months
Locations:
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson in Katy
state: Texas
city: Nassau Bay
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
city: The Woodlands
country: United States
facility: MD Anderson in The Woodlands
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gaiane M Rauch
role: PRINCIPAL_INVESTIGATOR
References: