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| ID | Type | Description | Link |
|---|---|---|---|
| 11-007860 | Other Identifier | Mayo Clinic Institutional Review Board |
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The purpose of this research study is to better understand the reasons why or why not breast cancers are destroyed by standard chemotherapy. This information will be used to develop new and better cancer therapies.
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| Measure | Description | Time Frame |
|---|---|---|
| DNA From the Germline and Breast Tumor for the Identification of Novel Somatic Changes Within Gene and Gene Pathways. | To obtain DNA from the germline and breast tumor for the identification of novel somatic changes within gene and gene pathways that are potentially "druggable" in men or women with breast cancer undergoing a standard neoadjuvant paclitaxel (with or without trastuzumab), followed by a standard anthracycline containing regimen (e.g. doxorubicin and cyclophosphamide) for breast cancer. We will report the median frequency and range of mutations observed for 30 mutated genes of interest. | 1 year 3 months |
| Frequency of Known Tumor Mutations for Which Current Drug Therapies Already Exist. | To determine the number of patients with one or more known tumor mutations for which current drug therapies already exist (e.g. BRAF, C-KIT, EGFR mutation, KRAS, PTEN, PI3K). | 1 year 3 months |
| Association Between Breast Cancer Events and Patient-derived Xenografts (PDX) Engraftment | Using breast cancer tissue obtained prior to chemotherapy in all patients and following the completion of chemotherapy (in patients with residual tumors > 2 cm or residual nodal disease), to develop tumor xenograft cell lines for mechanistic and functional studies to determine whether mutations identified are associated with the malignant phenotype and response to associated drugs which target the gene and/or pathways. The breast cancer relapse rate of patients that received pre-NAC PDX engraftment will be reported. | 1 year 3 months |
| Somatic Alterations Identified Are Associated With Pathologic Complete Response to Therapy. | To determine whether somatic alterations identified above are associated with pathologic complete response (pCR) to therapy. The number of patients experiencing a pCR with one or more somatic alterations will be reported. | 1 year 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 99mTc-sestamibi Uptake and Pathologic Response Following Neoadjuvant Chemotherapy. | Assess the association between changes in 99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy (MCR participants only). Sensitivity, specificity, positive predictive value, and negative predictive value after NAC at MRI and MBI will be reported. | 1 year 3 months |
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Inclusion Criteria:
Age ≥18 years.
Histological confirmation of invasive breast cancer.
Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast.
Men or women who are to begin neoadjuvant chemotherapy for treatment of Stage I-III Her 2 negative breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) or the combination of doxorubicin and cyclophosphamide (AC). OR Men or women who are to begin neoadjuvant chemotherapy for treatment of Stage I-III Her 2 positive breast cancer with paclitaxel followed by either the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) or the combination of doxorubicin and cyclophosphamide (AC). MC1137 Trastuzumab will be given concurrently with the taxane portion and can be given concurrently with FEC (but not AC) at the discretion of the medical oncologist.
Provide informed written consent.
Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up.
Willing to provide blood samples for correlative research purposes.
Willing to provide tissue samples for correlative research purposes.
ECOG Performance Status ≤ 2.
Exclusion Criteria:
Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.
Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
Patients who are not planning to receive neoadjuvant chemotherapy.
Biopsy proven Stage IV disease.
Patients who are pregnant or nursing.
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Matthew P. Goetz, M.D. | Mayo Clinic | Study Chair |
| Donald W. Northfelt, M.D. | Mayo Clinic campus in Arizona | Principal Investigator |
| Judy C. Boughey, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic campus in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41898311 | Derived | Bernal YA, Blanco A, Orostica K, Delgado I, Armisen R. Integration of RNA Editing into Multiomics Machine Learning Models for Predicting Drug Responses in Breast Cancer Patients. Biomedicines. 2026 Mar 14;14(3):665. doi: 10.3390/biomedicines14030665. | |
| 38858721 | Derived | Leon-Ferre RA, Whitaker KR, Suman VJ, Hoskin T, Giridhar KV, Moore RM, Al-Jarrad A, McLaughlin SA, Northfelt DW, Hunt KN, Conners AL, Moyer A, Carter JM, Kalari K, Weinshilboum R, Wang L, Ingle JN, Knutson KL, Ansell SM, Boughey JC, Goetz MP, Villasboas JC. Pre-treatment peripheral blood immunophenotyping and response to neoadjuvant chemotherapy in operable breast cancer. Breast Cancer Res. 2024 Jun 10;26(1):97. doi: 10.1186/s13058-024-01848-z. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals Aged 18 or Older With Stage I-III BC Who Plan to Undergo Neo-adjuvant Chemotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Individuals Aged 18 or Older With Stage I-III BC Who Plan to Undergo Neo-adjuvant Chemotherapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DNA From the Germline and Breast Tumor for the Identification of Novel Somatic Changes Within Gene and Gene Pathways. | To obtain DNA from the germline and breast tumor for the identification of novel somatic changes within gene and gene pathways that are potentially "druggable" in men or women with breast cancer undergoing a standard neoadjuvant paclitaxel (with or without trastuzumab), followed by a standard anthracycline containing regimen (e.g. doxorubicin and cyclophosphamide) for breast cancer. We will report the median frequency and range of mutations observed for 30 mutated genes of interest. | Pre-NAC tumor and germline sequencing data were generated for 122 patients | Posted | Median | Full Range | mutations | 1 year 3 months |
|
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Adverse events were not collected for this specimen collection trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individuals Aged 18 or Older With Stage I-III BC Who Plan to Undergo Neo-adjuvant Chemotherapy (NAC) | Patients received12 weeks of weekly paclitaxel (with trastuzumab for human epidermal growth factor receptor 2-positive [HER2+] malignancies), followed by four cycles of an anthracycline-based regimen. Surgery was performed following completion of NAC, and residual cancer burden (RCB) scores were calculated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew P. Goetz MD and Judy C. Boughey MD | Mayo Clinic | 507-284-2511 | Goetz.Matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2023 | Jul 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2014 | Aug 11, 2025 | ICF_001.pdf |
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Breast cancer tissue and blood specimens
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinical T-stage | T1 (includes T1a, T1b, and T1c): Tumor is 2 cm (3/4 of an inch) or less across. T2: Tumor is more than 2 cm but not more than 5 cm (2 inches) across. T3: Tumor is more than 5 cm across. T4 (includes T4a, T4b, T4c, and T4d): Tumor of any size growing into the chest wall or skin. This includes inflammatory breast cancer. | Count of Participants | Participants |
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| Clinical N-stage | N0: Cancer has not spread to nearby lymph nodes. N1: Cancer has spread to 1-3 axillary (underarm) lymph node(s), and/or cancer is found in internal mammary lymph nodes on sentinel lymph node biopsy. N2: Cancer has spread to 4-9 lymph nodes under the arm, or cancer has enlarged the internal mammary lymph nodes. N3: Cancer is found in at least one axillary lymph node (with at least one area of cancer spread greater than 2 mm) and has enlarged the internal mammary lymph nodes or cancer has spread to the lymph nodes under the collarbone or above the collarbone on the same side of the cancer | Count of Participants | Participants |
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| Primary | Frequency of Known Tumor Mutations for Which Current Drug Therapies Already Exist. | To determine the number of patients with one or more known tumor mutations for which current drug therapies already exist (e.g. BRAF, C-KIT, EGFR mutation, KRAS, PTEN, PI3K). | Pre-NAC tumor and germline sequencing data were generated for 122 patients | Posted | Count of Participants | Participants | 1 year 3 months |
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| Primary | Association Between Breast Cancer Events and Patient-derived Xenografts (PDX) Engraftment | Using breast cancer tissue obtained prior to chemotherapy in all patients and following the completion of chemotherapy (in patients with residual tumors > 2 cm or residual nodal disease), to develop tumor xenograft cell lines for mechanistic and functional studies to determine whether mutations identified are associated with the malignant phenotype and response to associated drugs which target the gene and/or pathways. The breast cancer relapse rate of patients that received pre-NAC PDX engraftment will be reported. | 113 patients had pre-NAC PDX engraftment | Posted | Number | percentage of patients | 1 year 3 months |
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| Primary | Somatic Alterations Identified Are Associated With Pathologic Complete Response to Therapy. | To determine whether somatic alterations identified above are associated with pathologic complete response (pCR) to therapy. The number of patients experiencing a pCR with one or more somatic alterations will be reported. | Posted | Count of Participants | Participants | 1 year 3 months |
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| Secondary | 99mTc-sestamibi Uptake and Pathologic Response Following Neoadjuvant Chemotherapy. | Assess the association between changes in 99mTc-sestamibi uptake and pathologic response following neoadjuvant chemotherapy (MCR participants only). Sensitivity, specificity, positive predictive value, and negative predictive value after NAC at MRI and MBI will be reported. | Only patients underwent both MRI and MBI after NAC | Posted | Number | percent | 1 year 3 months |
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| Sensitivity for MBI |
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| Positive predictive value for MBI |
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| Negative predictive- value for MBI |
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