NCI Community Oncology Research Program - Protocol Summary
NRG-BR005 - "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"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Breast Clinical Trial
CANCER TYPE: Stage II
RESEARCH BASE: NRG
NCT NUMBER: NCT03188393
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UPDATED ON 08/16/2018 (17:32:36)
Invasive ductal ca, stage II and IIIA, how well do tumor bed biopsies predict pathologic response when patient has had complete response to neoadjuvant chemo.
Treatment (Provided Drug: N/A)
- Initial biopsy clip placement
- Patient will be scheduled for stereotactic biopsy of the tumor bed
- An 8 to 11 G vacuum-assist device should be used for the biopsy with at least 10 mm length biopsy aperture
- Four cores should be obtained at 90 degree intervals with 2 additional cores directed in the area of the targeted clip
- Post-clip mammogram should be obtained with documentation of distance between the two clips if baseline clip is not retrieved
- All imaging related to the procedure should be submitted with case report forms including pre-treatment mammogram documenting biopsy clip placement within the tumor bed
- Breast conserving surgery will be performed as per usual local standards. Localization of the residual tumor using the biopsy clip will be performed as per institutional standards.
- The surgery of the axilla will also be performed as per institutional standards.
- Breast radiotherapy with or without regional nodal irradiation will be performed per local institutional guidelines.
- Adjuvant therapy (e.g., chemotherapy, HER2 targeted therapy, etc.) is at the investigator's discretion.
- In the absence of complications or unexpected outcomes, participation in the BR005 study will continue until the stereotactic biopsy is performed either before surgery or the day of surgery or until one of the following criteria applies:
- Intercurrent illness that prevents completion of the stereotactic biopsy procedure
- Complications or unexpected outcomes
- Patient decides to withdraw from the study
- General or specific changes in the patient's condition render the patient unacceptable for a stereotactic biopsy procedure in the judgment of the investigator
- Patient non-compliance
- Patients must have trimodality imaging (i.e., paid for by insurance and done prior to enrollment) to be eligible.
- The trial is open to female and male patients.
- Age ≥ 18 years.
- 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.
- No T4 tumors including inflammatory breast cancer.
- No Patients with metastatic disease.
- No Lumpectomy performed prior to study entry.
- No Patients with any history of prior radiation therapy in the affected breast.
- No 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.)
- No Patients with invasive lobular carcinoma.
- No Patients who have multicentric disease.
- No Patients treated with neoadjuvant hormonal therapy only are not eligible.
- No Patients who are medically unfit to undergo surgical resection.
- No Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy.
- No 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.
- No 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.
- No Pregnancy or lactation at the time of study registration.