NCT00542191

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Leo W. Jenkins Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2016-08-02
• Completion: 2016-08-02
• First posted: 2007-10-10
• Last updated: 2021-05-26
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States