NCI Community Oncology Research Program - Protocol Summary
Alliance A011104 - "EFFECT OF PREOPERATIVE BREAST MRI ON SURGICAL OUTCOMES, COSTS AND QUALITY OF LIFE OF WOMEN WITH BREAST CANCER"
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.
Cancer Control Clinical Trial
CANCER TYPE: Breast
RESEARCH BASE: Alliance
NCT NUMBER: NCT01805076
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Breast ca, stage I-II, elig for BCT, compare local recurrence rates following BCT using preop staging w/mammography + MRI vs mammography only. DCP-001 Eligible
THIS TRIAL IS DCP-001 ELIGIBLE
ACRIN requires pre-qualification of magnetic resonance imaging scanners prior to participant enrollment to the trial and must meet ACR requirements for image quality under the ACR accreditation program (see Appendix III).
Arm 1 (standard): Clinical breast examination and mammography (+/- tomogram if tomography is standard practice at the enrolling institution) with ultrasound (US) of breast and regional nodes (if US is a standard component of institutional preoperative assessments); followed by breast conserving surgery (BCS).
Arm 2 (experimental): Clinical breast examination, mammography (+/- tomogram if tomography is standard practice at the enrolling institution) with ultrasound (US) of breast and regional nodes (if US is a standard component of institutional preoperative assessments) and breast MRI; followed by breast conserving surgery (BCS) or mastectomy.
- Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.
- Patients must have either:
- ER negative/PR negative (<10% by IHC staining) and HER-2 negative breast cancer.
- ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors.
- HER2 status will be determined as per the 2013 ASCO CAP guidelines:
- HER2 is considered positive if a) there is IHC 3+ staining or b) ISH positive using either single probe ISH or dual probe ISH
- HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH
- No patients with previous ipsilateral invasive breast cancer or DCIS.
- No patients with bilateral breast cancer.
- No patients with known deleterious mutations in BRCA genes.
- No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures.
- No history of chemotherapy for cancer within 6 months prior to registration.
- No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery.
- Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.
- No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled.
- Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
- No history of untreatable claustrophobia;
- No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants);
- No history of sickle cell disease;
- No contraindication to intravenous contrast administration;
- No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance.
- No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 based on a creatinine level obtained within 28 days prior to registration;
- Weight lower than that allowable by the MRI table;
- No prior MRI of the study breast within the 12 months prior to registration.
- Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential.
- ≥ 18 years of age.
- Signed study-specific informed consent prior to registration.