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Study of Neoadjuvant Chemotherapy of Breast Cancer (Neoadjuvant)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Fernando Cabanillas, Auxilio Mutuo Cancer Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830544
First Posted: January 28, 2009
Last Update Posted: July 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Neoadjuvant chemotherapy Drug: Chemotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Chemotherapy of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:

Primary Outcome Measures:
  • To evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • To evaluate the clinical anti-tumor activity of the TEC combination chemotherapy regimen as judged by MRI when feasible or if not, with ultrasound. [ Time Frame: 2 years ]

Estimated Enrollment: 54
Study Start Date: July 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental chemotherapy using neoadjuvant approach
Drug: Neoadjuvant chemotherapy
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
Other Name: Neoadjuvant chemotherapy for breast cancer
Drug: Chemotherapy
Neoadjuvant chemotherapy
Other Name: Neoadjuvant chemotherapy with experimental strategy
Drug: Neoadjuvant chemotherapy
Experimental chemotherapy regimen
Other Name: Chemotherapy sequentially according to response

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Any evidence of bleeding diathesis or coagulopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830544


Locations
Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
Sanofi
Investigators
Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center
  More Information

Responsible Party: Fernando Cabanillas, Hematolgy-Oncologist, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier: NCT00830544     History of Changes
Other Study ID Numbers: CCAM 07-03
First Submitted: January 27, 2009
First Posted: January 28, 2009
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:
neoadjuvant chemotherapy breast cancer
Breast cancer patients with tumors over one cm

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases