Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials. |
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| Condition | Breast Cancer |
| Intervention | Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin Procedure: Definitive Surgery Radiation: Radiotherapy |
| Phase | Phase 2 |
| Sponsor | Leo W. Jenkins Cancer Center |
| Responsible Party | Leo W. Jenkins Cancer Center |
| ClinicalTrials.gov Identifier | NCT00542191 |
| First Received | October 9, 2007 |
| Last Updated | August 26, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 9, 2007 |
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| Last Updated Date | August 26, 2013 |
| Start Date | July 2007 |
| Estimated Primary Completion Date | June 2018 |
| Current Primary Outcome Measures | 1) Pathologic response [Time Frame: within 3 weeks of completing neoadjuvant chemotherapy] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | 1) Clinical response 2) Disease free survival (DFS) 3) Overall Survival (OS) [Time Frame: Ongoing clinical surveillance follow-up assessing Disease Free and Overall Survival] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer |
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| Official Title | Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer |
| Brief Summary | This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials. |
| Detailed Description | Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Procedure: Definitive Surgery Standard of care definitive surgery as determined by medical provider Radiation: Radiotherapy Standard of care RADIATION THERAPY as indicated |
| Study Arm (s) | Other: Single arm study; taxol, XRT, gemzar and carbo |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 28 |
| Estimated Completion Date | June 2018 |
| Estimated Primary Completion Date | December 2016 |
| Eligibility Criteria | Inclusion Criteria: - Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable) - Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.) - Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.) - Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3 - Normal myocardial left ventricular function - Serum creatinine < 2.0 mg/dl - Total bilirubin and AST < 3X upper limits normal Exclusion Criteria: - Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol) - Another active cancer present - Medical contraindications to chemotherapy or surgery - First trimester pregnancy - Breast feeding |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Paul Walker, MD 252-744-1888 walkerp@ecu.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00542191 |
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| Other Study ID Numbers | LJCC 07-03 |
| Has Data Monitoring Committee | No |
| Information Provided By | Leo W. Jenkins Cancer Center |
| Study Sponsor | Leo W. Jenkins Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Paul Walker, MD Brody School of Medicine at East Carolina University |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Brody School of Medicine at East Carolina University | Greenville, North Carolina, United States, 27834 Recruiting |
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