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

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.)