Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01)

Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01329640

Enrollment

Registered

2011-04-06

Start date

2010-09-30

Completion date

2012-09-30

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced HER2-positive Breast Cancer

Keywords

Metronimic chemotherapy, Locally Advanced HER2-positive Breast Cancer

Brief summary

The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.

Interventions

DEVICEDrug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide

1. Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by; 2. Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of locally advanced breast cancer * T \> 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm) * Non-metastatic disease confirmed by computerized tomography and bone scan * HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007) * Normal left ventricular ejection fraction (LVEF) * Indication of preoperative chemotherapy * multifocal tumors acceptable provided that the largest tumor is Her2-positive * ECOG 0-1

Exclusion criteria

* 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 such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders * LVEF value below institutional limits of normal range * Detected or suspected distant metastasis * Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN

Design outcomes

Primary

Measure	Time frame	Description
INCIDENCE OF FEBRILE NEUTROPENIA	18 weeks	INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%

Secondary

Measure	Time frame	Description
TUMOR SIZE	From the beginning of treatment until surgery, disease progression or death	Efficacy will be assessed by: 1. Tumor measurements using MRI of the Breast 2. Pathologic complete response 3. Progression-free survival 4. Overall survival

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026