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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin; Procedure: Definitive Surgery; Radiation: Radiotherapy

• Registration Number: NCT00542191
• Lead Sponsor: Leo W. Jenkins Cancer Center

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Primary Completion: 2016-08-02
• Study Completion: 2016-08-02
• Results First Submitted: 2018-03-13
• Results First Submitted QC: 2019-08-19
• Results First Posted: 2019-09-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant metronomic AC followed by weekly TC	Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin	Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
Neoadjuvant metronomic AC followed by weekly TC	Definitive Surgery	Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
Neoadjuvant metronomic AC followed by weekly TC	Radiotherapy	Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery

Primary Outcome Measures

Name	Time	Method
1) Pathologic Response	Upon completion therapy after surgery	Pathologic measurement post-surgery viable primary tumor mass

Trial Locations

Locations (1)

Brody School of Medicine at East Carolina University; 🇺🇸 Greenville, North Carolina, United States