Predicting pathologic response using tumor bed biopsies in patients with complete response after neoadjuvant chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0003445
- Lead Sponsor
- RG Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 5
The patient must have an ECOG Performance status of 0 or 1 (see Appendix A).
-Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing (http://www.asco.org).
-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 (http://www.asco.org). 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 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.
-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 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.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the proportion of patients with post-neoadjuvant chemotherapy negative image-directed biopsy that have a pCR
- Secondary Outcome Measures
Name Time Method umber of needle cores performed and the proportion of clips retrieved;the distribution of residual cancer burden score;Trimodality imaging algorithm +/- biopsy as a predictor of pCR