Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

After completion of neoadjuvant therapy, patients undergo stereotactic biopsy of breast tumor any time prior to breast conserving surgery. Patients then undergo breast conserving surgery as per standard of care. Patients may also undergo postoperative radiation therapy per standard of care or adjuvant therapy at the investigator's discretion.

Biopsy of Breast

Mark Basik

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.

PRIMARY OBJECTIVES:

I. To assess the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and ductal carcinoma in situ (DCIS), in cases of clinical and radiologic complete response with trimodality imaging.

SECONDARY OBJECTIVES:

I. To collect axillary pathology results, surgical staging methods (sentinel lymph node biopsy and/or axillary lymph node dissection), and management (surgery and/or radiation) in order to determine axillary nodal response to neoadjuvant chemotherapy and its relationship to breast pCR.

II. To correlate imaging results with pathologic nodal status following neoadjuvant chemotherapy for future planning of axillary management in the next study.

III. To retrospectively assess the negative predictive value (NPV) of a trimodality imaging algorithm in combination with the tumor bed biopsy for predicting pCR.

IV. To collect all trimodality imaging data to determine which combination of the trimodality imaging best identifies the group achieving pCR.

V. To correlate the number of needle cores and tumor bed clip retrieval with the NPV of the tumor site biopsy.

VI. To determine the clinical, imaging, pathologic, and molecular tumor factors associated with the highest NPVs of post-NST tumor bed biopsies.

VII. To improve identification and selection of patients with breast and possible axillary pCR for future trial planning, routine biomarkers (estrogen receptor \[ER\], progesterone receptor \[PR\], HER2 neu, and Ki67) will be collected to allow comparison to image/clinical complete response (CR), and tumor bed biopsies.

OUTLINE:

After completion of neoadjuvant therapy, patients undergo stereotactic biopsy of breast tumor any time prior to breast conserving surgery. Patients then undergo breast conserving surgery as per standard of care. Patients may also undergo postoperative radiation therapy per standard of care or adjuvant therapy at the investigator's discretion.

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

Analysis to assess the association of molecular markers with response to neoadjuvant therapy.

The proportion of tumor bed biopsies that are negative among those who are shown to have pCR at surgery will be determined. The point estimate and 95% confidence interval will be calculated.

Analysis will be performed to assess the improvement in the negative predictive value of the trimodality imaging algorithm when the results of tumor bed biopsy are added.

Descriptive analysis will be performed to determine the frequencies of adverse events associated with tumor bed biopsy.

Descriptive analysis will be performed to determine the distribution of the number of needle cores performed and the proportion of clips retrieved.

Descriptive analysis will be performed to determine the distribution of residual cancer burden score.

National Cancer Institute (NCI)

NRG Oncology

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Congenital Abnormalities

Calcinosis

Metabolic Diseases

Calcium Metabolism Disorders

Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.

Ultrasound

MicoPure ultrasound

Undergo breast biopsy or surgical resection

Flemming Forsberg, PhD

This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

PRIMARY OBJECTIVES:

I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.

SECONDARY OBJECTIVES:

I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).

II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.

III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality

Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)

The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.

Sidney Kimmel Cancer Center at Thomas Jefferson University

All Drugs and Chemicals

Technetium Tc 99m Sestamibi

Radiopharmaceuticals

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

Utilization of the Stereo Navigator accessory

Medical Device Usage and Evaluation

Scintimammography

Technetium Tc-99m Sestamibi

Clinical Trials Referral Office

Katie N. Hunt, M.D.

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

PRIMARY OBJECTIVE:

I. To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions.

OUTLINE: Patients are assigned to 1 of 2 study parts.

PART I: Patients receive technetium Tc-99m sestamibi intravenously (IV) and undergo MBI on study.

PART II: Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

After completion of study intervention, patients may be asked to follow up at 3-6 months.

Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities

Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.

The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.

For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

Mayo Clinic

Carcinoma, Lobular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Amino Acids

Neratinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

Endocrine Therapy

Biopsy of breast

Biospecimen Collection

Mammogram

Undergo breast Magnetic Resonance Imaging

Magnetic Resonance Imaging

Breast Surgery

Vanderbilt-Ingram Services for Timely Access

Kevin Kalinsky, MD

Adam Brufsky, MD

Vanderbilt-Ingram Service for Timely Access

Laura Kennedy, MD, PhD

Carlos Arteaga, MD

Bora Lim, MD

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

PRIMARY OBJECTIVE:

I. Determine efficacy of neoadjuvant neratinib in combination with endocrine therapy.

SECONDARY OBJECTIVES:

I. Determine additional efficacy outcomes of neoadjuvant neratinib in combination with endocrine therapy.

II. Compare the safety and tolerability of neratinib plus endocrine therapy.

CORRELATIVE OBJECTIVE:

I. Establish HER2-mutant invasive lobular carcinoma (ILC) organoids.

OUTLINE: Patients are randomized to 1 of 2 treatments.

TREATMENT A: Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then endocrine therapy and neratinib orally (PO) daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast magnetic resonance imaging (MRI) prior to surgery.

TREATMENT B: Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

After completion of study treatment, patients are followed up for 4 weeks after study drugs interruption.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery	NCT03188393	Invasive Breast... Stage II Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea...	Biopsy of Breas...	18 Years -	NRG Oncology
Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery	NCT03188393	Invasive Breast... Stage II Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea...	Biopsy of Breas...	18 Years -	NRG Oncology
Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality	NCT03031561	Breast Carcinom... Microcalcificat...	Ultrasound MicoPure ultras... Biopsy of Breas...	18 Years -	Thomas Jefferson University
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers	NCT05919108	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Invasive Breast...	Endocrine Thera... Biopsy of breas... Neratinib Biospecimen Col... Mammogram Magnetic Resona... Breast Surgery Ultrasound	18 Years -	Vanderbilt-Ingram Cancer Center
Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality	NCT03031561	Breast Carcinom... Microcalcificat...	Ultrasound MicoPure ultras... Biopsy of Breas...	18 Years -	Thomas Jefferson University
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers	NCT05919108	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Invasive Breast...	Endocrine Thera... Biopsy of breas... Neratinib Biospecimen Col... Mammogram Magnetic Resona... Breast Surgery Ultrasound	18 Years -	Vanderbilt-Ingram Cancer Center

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