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

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ClinicalTrials.gov Identifier: NCT03188393
Recruitment Status : Unknown
Verified April 2017 by NRG Oncology.
Recruitment status was:  Recruiting
First Posted : June 15, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 15, 2017
Last Update Posted Date June 27, 2017
Actual Study Start Date  ICMJE April 13, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Proportion of patients with pCR [ Time Frame: Up to 18 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03188393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • Improvement of negative predictive value [ Time Frame: Up to 18 months ]
    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.
  • Incidence of adverse events associated with tumor bed biopsy [ Time Frame: Up to 18 months ]
    Descriptive analysis will be performed to determine the frequencies of adverse events associated with tumor bed biopsy.
  • Number of needle cores performed [ Time Frame: Up to 18 months ]
    Descriptive analysis will be performed to determine the distribution of the number of needle cores performed and the proportion of clips retrieved.
  • Proportion of clips retrieved [ Time Frame: Up to 18 months ]
    Descriptive analysis will be performed.
  • Residual cancer burden score [ Time Frame: Up to 18 months ]
    Descriptive analysis will be performed to determine the distribution of residual cancer burden score.
  • Trimodality imaging algorithm +/- biopsy as a predictor of pCR [ Time Frame: Up to18 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Invasive Breast Carcinoma
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
Intervention  ICMJE Procedure: Biopsy of Breast
Undergo stereotactic biopsy
Other Name: Breast Biopsy
Study Arms  ICMJE Experimental: Diagnostic (biopsy of breast)
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.
Intervention: Procedure: Biopsy of Breast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
175
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing
  • Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible
  • Patients must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy
  • Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
  • Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI
  • Patients must be undergoing breast conserving therapy
  • Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy
  • Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
  • Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible
  • Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible

Exclusion Criteria:

  • T4 tumors including inflammatory breast cancer
  • Patients with metastatic disease
  • Lumpectomy performed prior to study entry
  • Patients with any history of prior radiation therapy in the affected breast
  • Patients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)
  • Patients with invasive lobular carcinoma
  • Patients who have multicentric disease
  • Patients treated with neoadjuvant hormonal therapy only are not eligible
  • Patients who are medically unfit to undergo surgical resection
  • Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy
  • Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography)
  • Patients with one or more of the following imaging criteria from any of the 3 imaging modalities after completion of neoadjuvant chemotherapy (NCT) are not eligible:

    • Mammogram with malignant appearing calcifications or mass > 1 cm; or
    • Ultrasound with a hypoechoic area > 2 cm; or
    • Breast MRI demonstrating a residual mass with rapid rise and washout type III kinetics.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
  • Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03188393
Other Study ID Numbers  ICMJE NRG-BR005
NCI-2016-01825 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-BR005
NRG-BR005 ( Other Identifier: NRG Oncology )
NRG-BR005 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NRG Oncology
Study Sponsor  ICMJE NRG Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark Basik NRG Oncology
PRS Account NRG Oncology
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP