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

Not Recruiting

Trial ID: NCT03188393


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
Irene Wapnir, MD

Professor of Surgery (General 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

   - At the time of consent, the patient's intent must be to undergo breast conserving

   - 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

   - 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.)


procedure: Biopsy of Breast

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Bucknell

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