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

NCT ID: NCT00542191

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2016-08-02

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant metronomic AC followed by weekly TC

Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery

Group Type: EXPERIMENTAL

Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin

Intervention Type: DRUG

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

Definitive Surgery

Intervention Type: PROCEDURE

Standard of care definitive surgery as determined by medical provider

Radiotherapy

Intervention Type: RADIATION

Standard of care RADIATION THERAPY as indicated

Interventions

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

Intervention Type: DRUG

Definitive Surgery

Standard of care definitive surgery as determined by medical provider

Intervention Type: PROCEDURE

Radiotherapy

Standard of care RADIATION THERAPY as indicated

Intervention Type: RADIATION

Other Intervention Names

Metronomic

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Leo W. Jenkins Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Brody School of Medicine at East Carolina University

Locations

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Countries

United States

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Other Identifiers

LJCC 07-03

Identifier Type: -

Identifier Source: org_study_id