NCT00830544

Brief Summary

The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2008

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

3.4 years

First QC Date

January 27, 2009

Last Update Submit

July 12, 2012

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy breast cancerBreast cancer patients with tumors over one cm

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma

    2 years

Secondary Outcomes (1)

  • To evaluate the clinical anti-tumor activity of the TEC combination chemotherapy regimen as judged by MRI when feasible or if not, with ultrasound.

    2 years

Study Arms (1)

1

EXPERIMENTAL

Experimental chemotherapy using neoadjuvant approach

Drug: Neoadjuvant chemotherapyDrug: Chemotherapy

Interventions

Neoadjuvant chemotherapyDRUG

Docetaxel 75 mg/m2, day 1 Epirubicin 80 mg/m2, day 1 Cyclophosphamide 500 mg/m2, day 1 Navelbine 25 mg/M2 in 250 cc NS over 60 min on day 1 and day 8 Bevacizumab 5 mg/kg in 100 cc NS over 90 min day 1 and day 8 Capecitabine 825 mg/M2 p.o. bid from day 1-14. Trastuzumab

Also known as: Neoadjuvant chemotherapy for breast cancer
1
ChemotherapyDRUG

Neoadjuvant chemotherapy

Also known as: Neoadjuvant chemotherapy with experimental strategy
1

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
  • Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinomas will also be eligible.
  • Age \> 18 years
  • Tumor \> 1.0 cm by MRI and/or sonographic or clinical exam measurements.Although only tumors \> 2 cm are considered measurable by RECIST criteria, we will nevertheless include tumors \> 1 cm since the primary endpoint is pathological CR rate.
  • Performance Status ECOG \<2 or Karnofsky \>50%
  • Peripheral neuropathy \< grade 1
  • Hematologic (minimal values):
  • Absolute neutrophil count \> 1,500/mm3
  • Hemoglobin \> 8.0 g/dl
  • Platelet count \> 100,000/mm3
  • Hepatic
  • Total Bilirubin normal
  • AST and ALT and Alkaline Phosphatase do not have to be within the range. In determining eligibility the more abnormal of the two values (AST or ALT) should be used as shown below.

You may not qualify if:

  • Pregnant or breast feeding patients are excluded.
  • Patients with second malignancies with expected survival \< 5 years.
  • Previous chemotherapy with either Taxanes, Anthracyclines or Cyclophosphamide.
  • Patients with history of severe hypersensitivity reaction to Taxotere (Docetaxel) or other drugs formulated with polysorbate 80.
  • Pure DCIS diagnoses are not eligible.
  • Special histologies with favorable prognosis such as mucinous, tubular are not eligible.
  • Patients with reduced ejection fraction \<50% are not eligible.
  • Patients with tumors \< 1.0 cm
  • Cardiac thrombotic events in the past 12 months
  • Stroke or transient ischemic attacks (TIA) within 12 months
  • Poorly controlled hypertension defined as persistent blood pressure elevation \>150 systolic and/or 100 diastolic not responsive to medications
  • GI condition that increases risk of perforation within 6 months of study
  • Any serious non-healing wound, ulcer, or bone fracture
  • No minor surgical procedure within 7 day of study entry or major surgery within 28 days of study entry or anticipation of need for major surgical procedure during the course of the study
  • Significant vascular disease such as symptomatic peripheral vascular disease
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auxilio Mutuo Cancer Center

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant TherapyDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Fernando Cabanillas, MD

    Auxilio Mutuo Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hematolgy-Oncologist

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

PR(1)