Clinical trial · Observational
Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer
NCT00033397CI-TRIAL-00028623completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Comparing results of diagnostic procedures performed before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment. PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| gadopentetate dimeglumine | Radiation | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| radiomammography | Procedure | — | UNRESOLVED |
| ultrasound imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Arm A
- description
- Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 1-3 days after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan. Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery). Patients are followed every 6 months for 5 years and then annually for up to 10 years.
- interventionNames
- Procedure: biopsy
- Procedure: magnetic resonance imaging
- Procedure: radiomammography
- Procedure: ultrasound imaging
- Radiation: gadopentetate dimeglumine
- Drug: chemotherapy
Primary outcomes (1)
- measure
- response
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle biopsy, incisional biopsy, or fine needle aspiration (FNA) * Incisional biopsy must result in \< 10% removal of gross residual disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan OR * Nonmeasurable disease * Meets one of the following staging criteria: * Stage II or III disease * T4, any N, M0, including clinical or pathologic inflammatory disease * Regional stage IV disease where supraclavicular/infraclavicular lymph nodes are only site of metastasis * No clinical or imaging evidence of distant metastasis * Metaplastic carcinomas allowed * Synchronous bilateral primaries allowed if the more advanced tumor meets staging criteria * Patients for whom FNA was used to confirm initial diagnosis must have histologically confirmed invasive carcinoma by the start of chemotherapy * Her-2/neu status known * Currently receiving neoadjuvant chemotherapy consisting of a taxane-based regimen alone or followed by an anthracycline-based regimen * Concurrent enrollment in the ACRIN-6657/CALGB-150012 imaging protocol required * Hormone receptor status: * Any estrogen receptor or progesterone receptor status PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Cardiovascular * No uncontrolled or severe cardiovascular disease Other * Not pregnant or nursing * Negative pregnancy test * No ferromagnetic prostheses including the following: * Metallic implants not compatible with a magnetic resonance imaging machine * Heart valves * Aneurysm clips * Orthopedic prosthesis * Any metallic fragments anywhere in the body PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics * No prior chemotherapy to the ipsilateral breast for this malignancy Endocrine therapy * At least 4 weeks since prior tamoxifen or raloxifene Radiotherapy * No prior radiotherapy to the ipsilateral breast for this malignancy Other * No other prior cytotoxic regimens
References
Publications (16)
- BACKGROUNDCarey LA, Oh D, Sawyer L, et al.: Gene expression subtype and p53 mutational status are correlated among neoadjuvantly treated breast cancers in UNC LCCC9819 and I-SPY1 (CALGB 150007/ACRIN 6657). [Abstract] J Clin Oncol 24 (Suppl 18): A-10048, 552s, 2006.
- RESULTEsserman LJ, Berry DA, Cheang MC, Yau C, Perou CM, Carey L, DeMichele A, Gray JW, Conway-Dorsey K, Lenburg ME, Buxton MB, Davis SE, van't Veer LJ, Hudis C, Chin K, Wolf D, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Livasy C, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, Au A, Hylton N; I-SPY 1 TRIAL Investigators. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat. 2012 Apr;132(3):1049-62. doi: 10.1007/s10549-011-1895-2. Epub 2011 Dec 25. PMID 22198468
- RESULTEsserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200/JCO.2011.39.2779. Epub 2012 May 29. PMID 22649152
- RESULTLin C, Buxton MB, Moore D, Krontiras H, Carey L, DeMichele A, Montgomery L, Tripathy D, Lehman C, Liu M, Olapade O, Yau C, Berry D, Esserman LJ; I-SPY TRIAL Investigators. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial). Breast Cancer Res Treat. 2012 Apr;132(3):871-9. doi: 10.1007/s10549-011-1670-4. Epub 2011 Jul 28. PMID 21796368
- RESULTEsserman LJ, Perou C, Cheang M, et al.: Breast cancer molecular profiles and tumor response of neoadjuvant doxorubicin and paclitaxel: The I-SPY TRIAL (CALGB 150007/150012, ACRIN 6657). [Abstract] J Clin Oncol 27 (Suppl 15): A-LBA515, 2009.