Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer

NCT01329627 | Terminated Phase 2

• 1 other identifier: NP 50/2010 - TAME
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.

Conditions

Locally Advanced HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia

  Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%

  18 weeks

Secondary Outcomes (1)

• Efficacy

  From the beginning of treatment until surgery, progression and death

Study Arms (1)

Paclitaxel/doxorubicin/cyclophosphamide

EXPERIMENTAL

Drug: Paclitaxel/doxorubicin/cyclophosphamide

Interventions

Paclitaxel/doxorubicin/cyclophosphamide DRUG

Metronomic chemotherapy as described below: 1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; 2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Also known as: Metronomic chemotherapy

Paclitaxel/doxorubicin/cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced breast cancer diagnosed by guided core biopsy
• T \> 2 cm (any N), or any T and node positive (needle biopsy is required)
• Non-metastatic disease assessed by computed tomography and bone scintigraphy
• Histological grade 2 and Ki67 \> 15% or
• Histological grade 3 or
• Any triple negative (TN) or
• Inflammatory breast cancer (IBC)
• Normal left ventricular ejection fraction (LVEF)
• HER2-negative disease

You may not qualify if:

• Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
• Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
• LVEF value below institutional limits of normal
• Predominant lobular carcinoma histology
• Grade 1 tumors
• Detected or suspicious distant metastasis
• Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
• Male sex
• HER2-positive breast cancer

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Fundação Faculdade de Medicina: collaborator

Study Sites (1)

State of Sao Paulo Cancer Institute

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Interventions

Paclitaxel; AC protocol

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: April 6, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

BR (1)