©2022 Stanford Medicine
Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
Not Recruiting
Trial ID: NCT03188393
Purpose
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.
Official Title
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
Stanford Investigator(s)
Irene Wapnir, MD
Professor of Surgery (General Surgery)
Eligibility
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 who have a primary tumor that is hormone
receptor-positive or hormone receptor-negative are eligible.
- 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 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
- Patients with operable focal or multifocal (T1-T3, stage II or III invasive ductal
carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy
with a clinical complete response (by clinical examination)
- Patients with synchronous bilateral breast cancer are eligible if at least one of the
synchronous breast cancers has a cCR, and the side with a cCR meets criteria.
(Patients with previous contralateral invasive breast cancer treated with anti-cancer
therapy are eligible.)
- 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 calcification or mass ≤ 1 cm; or
- Ultrasound with a hypoechoic area ≤ 2 cm; or
- Breast MRI not demonstrating a residual mass with rapid rise and washout type III
kinetics.
- At the time of consent, the patient's intent must be to undergo breast conserving
therapy.
- 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.)
- Patient must have completed neoadjuvant chemotherapy.
- 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.
Exclusion Criteria:
- T4 tumors including inflammatory breast cancer
- Patients with distant metastatic disease
- Lumpectomy performed prior to study entry
- Patients with any history of prior radiation therapy in the affected breast
- Patients with a 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 with one or more of the following imaging criteria from any of the 3 imaging
modalities after completion of NCT demonstrating incomplete radiologic response 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.)
Intervention(s):
procedure: Biopsy of Breast
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathryn Bucknell
650-723-0659