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Biopsy of Breast after Chemotherapy in Predicting Pathologic Response in Patients with Breast Cancer Undergoing Breast Conserving Surgery

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Diagnostic
NCT ID
NCT03188393
Protocol IDs
NRG-BR005 (primary)
NCI-2016-01825
Study Sponsor
NRG Oncology

Summary

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with 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.

Objectives

PRIMARY OBJECTIVE:
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.

EXPLORATORY OBJECTIVES:
I. To assess molecular markers associated with response to neoadjuvant therapy.

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.

Eligibility

  1. The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. 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 who have a primary tumor that is hormone receptor-positive or hormone receptor-negative are eligible
  4. 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
  5. Patients must have had 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
  6. Patients with operable focal or multifocal (T1-T3, N0-N1 invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
  7. Patients with synchronous bilateral breast cancer are eligible if at least one of the synchronous breast cancers has a clinical complete response (cCR), and the side with a cCR; (Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible.)
  8. Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI during or after completion of appropriate neoadjuvant chemotherapy defined as: * Mammogram with malignant appearing calcifications or mass =< 1 cm; and * Ultrasound with a hypoechoic area =< 2 cm; and * Breast MRI not demonstrating a residual mass with rapid rise and washout type III kinetics * Note: A negative study (i.e., no evidence of abnormality) on each imaging modality is also acceptable
  9. At the time of consent, the patient's intent must be to undergo breast conserving therapy
  10. Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy; (The patient must be enrolled on the study before performing the post-neoadjuvant stereotactic-vacuum-assisted breast biopsy.)
  11. Patient must have completed appropriate institutional neoadjuvant chemotherapy
  12. 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
  13. Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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